Displaying publications 1 - 20 of 38 in total

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  1. Suthar SK, Boon HL, Sharma M
    Eur J Med Chem, 2014 Mar 3;74:135-44.
    PMID: 24457265 DOI: 10.1016/j.ejmech.2013.12.052
    The C-3, C-17 and C-22 congeners of pentacyclic triterpenoids reduced lantadene A (3), B (4) and 22β-hydroxyoleanolic acid (5) were synthesized and were tested in vitro for their NF-κB and IKKβ inhibitory potencies and cytotoxicity against A549 lung cancer cells. The lead congeners 12 and 13 showed IC50 of 0.56 and 0.42 μmol, respectively against TNF-α induced activation of NF-κB. The congeners 12 and 13 exhibited inhibition of IKKβ in a single-digit micromolar dose and at the same time, 12 and 13 showed marked cytotoxicity against A549 lung cancer cells with IC50 of 0.12 and 0.08 μmol, respectively. The lead ester congeners were stable in the acidic pH, while hydrolyzed readily in the human blood plasma to release the active parent moieties.
  2. Sharma M, Agarwal S, Acharya UR
    Comput. Biol. Med., 2018 09 01;100:100-113.
    PMID: 29990643 DOI: 10.1016/j.compbiomed.2018.06.011
    Obstructive sleep apnea (OSA) is a sleep disorder caused due to interruption of breathing resulting in insufficient oxygen to the human body and brain. If the OSA is detected and treated at an early stage the possibility of severe health impairment can be mitigated. Therefore, an accurate automated OSA detection system is indispensable. Generally, OSA based computer-aided diagnosis (CAD) system employs multi-channel, multi-signal physiological signals. However, there is a great need for single-channel bio-signal based low-power, a portable OSA-CAD system which can be used at home. In this study, we propose single-channel electrocardiogram (ECG) based OSA-CAD system using a new class of optimal biorthogonal antisymmetric wavelet filter bank (BAWFB). In this class of filter bank, all filters are of even length. The filter bank design problem is transformed into a constrained optimization problem wherein the objective is to minimize either frequency-spread for the given time-spread or time-spread for the given frequency-spread. The optimization problem is formulated as a semi-definite programming (SDP) problem. In the SDP problem, the objective function (time-spread or frequency-spread), constraints of perfect reconstruction (PR) and zero moment (ZM) are incorporated in their time domain matrix formulations. The global solution for SDP is obtained using interior point algorithm. The newly designed BAWFB is used for the classification of OSA using ECG signals taken from the physionet's Apnea-ECG database. The ECG segments of 1 min duration are decomposed into six wavelet subbands (WSBs) by employing the proposed BAWFB. Then, the fuzzy entropy (FE) and log-energy (LE) features are computed from all six WSBs. The FE and LE features are classified into normal and OSA groups using least squares support vector machine (LS-SVM) with 35-fold cross-validation strategy. The proposed OSA detection model achieved the average classification accuracy, sensitivity, specificity and F-score of 90.11%, 90.87% 88.88% and 0.92, respectively. The performance of the model is found to be better than the existing works in detecting OSA using the same database. Thus, the proposed automated OSA detection system is accurate, cost-effective and ready to be tested with a huge database.
  3. Sharma M, Tan RS, Acharya UR
    Comput. Biol. Med., 2018 11 01;102:341-356.
    PMID: 30049414 DOI: 10.1016/j.compbiomed.2018.07.005
    Myocardial infarction (MI), also referred to as heart attack, occurs when there is an interruption of blood flow to parts of the heart, due to the acute rupture of atherosclerotic plaque, which leads to damage of heart muscle. The heart muscle damage produces changes in the recorded surface electrocardiogram (ECG). The identification of MI by visual inspection of the ECG requires expert interpretation, and is difficult as the ECG signal changes associated with MI can be short in duration and low in magnitude. Hence, errors in diagnosis can lead to delay the initiation of appropriate medical treatment. To lessen the burden on doctors, an automated ECG based system can be installed in hospitals to help identify MI changes on ECG. In the proposed study, we develop a single-channel single lead ECG based MI diagnostic system validated using noisy and clean datasets. The raw ECG signals are taken from the Physikalisch-Technische Bundesanstalt database. We design a novel two-band optimal biorthogonal filter bank (FB) for analysis of the ECG signals. We present a method to design a novel class of two-band optimal biorthogonal FB in which not only the product filter but the analysis lowpass filter is also a halfband filter. The filter design problem has been composed as a constrained convex optimization problem in which the objective function is a convex combination of multiple quadratic functions and the regularity and perfect reconstruction conditions are imposed in the form linear equalities. ECG signals are decomposed into six subbands (SBs) using the newly designed wavelet FB. Following to this, discriminating features namely, fuzzy entropy (FE), signal-fractal-dimensions (SFD), and renyi entropy (RE) are computed from all the six SBs. The features are fed to the k-nearest neighbor (KNN). The proposed system yields an accuracy of 99.62% for the noisy dataset and an accuracy of 99.74% for the clean dataset, using 10-fold cross validation (CV) technique. Our MI identification system is robust and highly accurate. It can thus be installed in clinics for detecting MI.
  4. Monika, Sharma A, Suthar SK, Aggarwal V, Lee HB, Sharma M
    Bioorg. Med. Chem. Lett., 2014 Aug 15;24(16):3814-8.
    PMID: 25027934 DOI: 10.1016/j.bmcl.2014.06.068
    The new series of pentacyclic triterpenoids reduced lantadene A (3), B (4), and 22β-hydroxy-3-oxo-olean-12-en-28-oic acid (5) analogs were synthesized and tested in vitro for their NF-κB and IKKβ inhibitory potencies and cytotoxicity against A549 lung cancer cells. The lead analog (11) showed sub-micromolar activity against TNF-α induced activation of NF-κB and exhibited inhibition of IKKβ in a single-digit micromolar dose. At the same time, 11 showed promising cytotoxicity against A549 lung cancer cells with IC50 of 0.98 μM. The Western blot analysis further showed that the suppression of NF-κB activity by the lead analog 11 was due to the inhibition of IκBα degradation, a natural inhibitor of NF-κB. The physicochemical evaluation demonstrated that the lead analog 11 was stable in the simulated gastric fluid of pH 2, while hydrolyzed at a relatively higher rate in the human blood plasma to release the active parent moieties. Molecular docking analysis showed that 11 was hydrogen bonded with the Arg-31 and Gln-110 residues of the IKKβ.
  5. Quar TK, Ching TY, Newall P, Sharma M
    Int J Audiol, 2013 May;52(5):322-32.
    PMID: 23570290 DOI: 10.3109/14992027.2012.755740
    The study aims to compare the performance of hearing aids fitted according to the NAL-NL1 and DSL v5 prescriptive procedure for children.
  6. Goel S, Arora J, Mehta V, Sharma M, Suri RK, Rath G, et al.
    Clin Ter, 2015;166(3):114-7.
    PMID: 26152618 DOI: 10.7417/CT.2015.1840
    The knowledge of variant anatomy of medial compartment of thigh is extremely important in surgical procedures requiring obturator nerve block. The nerve block is also recommended for providing additional analgesia following major knee surgeries and for relieving painful adductor muscle spasm. The interfascial injection technique is commonly followed in ultrasound guided obturator nerve block. For this procedure it is imperative to identify the adductor muscles on sonography to inject the anesthetic solution in the intermuscular fascial planes. The presence of an additional muscle can prove useful in myocutaneous flap surgeries for reconstruction especially of perineum. We hereby report a case of such an anomalous supernumerary adductor muscle present between adductor brevis and proximal part of adductor magnus, in an adult Indian male cadaver, recorded during routine dissection in Department of Anatomy, Vardhman Mahavir Medical College and Safdarjung Hospital. The muscle was innervated by the posterior division of obturator nerve. The morphology, embryological basis and clinical aspects are also discussed.
  7. Hansdak R, Arora J, Sharma M, Mehta V, Suri RK, Das S
    Clin Ter, 2015;166(2):65-7.
    PMID: 25945432 DOI: 10.7417/CT.2015.1817
    Variations in the arterial pattern of upper limb are of colossal importance to the surgeons as they are liable to iatrogenic injuries. During routine dissection for undergraduate medical students, an anomaly of brachial artery was discovered. The brachial artery terminated at higher level into ulnar and radial artery. The common interosseus artery took origin arising from radial artery. The ulnar artery did not give any branches in the forearm. Both radial and ulnar artery displayed a superficial course in the forearm. The anatomical knowledge of these variations may be of great help for the clinicians in planning and conducting flap harvesting during reconstructive surgeries and in arteriography.
  8. Sharma M, Goyal D, Achuth PV, Acharya UR
    Comput. Biol. Med., 2018 07 01;98:58-75.
    PMID: 29775912 DOI: 10.1016/j.compbiomed.2018.04.025
    Sleep related disorder causes diminished quality of lives in human beings. Sleep scoring or sleep staging is the process of classifying various sleep stages which helps to detect the quality of sleep. The identification of sleep-stages using electroencephalogram (EEG) signals is an arduous task. Just by looking at an EEG signal, one cannot determine the sleep stages precisely. Sleep specialists may make errors in identifying sleep stages by visual inspection. To mitigate the erroneous identification and to reduce the burden on doctors, a computer-aided EEG based system can be deployed in the hospitals, which can help identify the sleep stages, correctly. Several automated systems based on the analysis of polysomnographic (PSG) signals have been proposed. A few sleep stage scoring systems using EEG signals have also been proposed. But, still there is a need for a robust and accurate portable system developed using huge dataset. In this study, we have developed a new single-channel EEG based sleep-stages identification system using a novel set of wavelet-based features extracted from a large EEG dataset. We employed a novel three-band time-frequency localized (TBTFL) wavelet filter bank (FB). The EEG signals are decomposed using three-level wavelet decomposition, yielding seven sub-bands (SBs). This is followed by the computation of discriminating features namely, log-energy (LE), signal-fractal-dimensions (SFD), and signal-sample-entropy (SSE) from all seven SBs. The extracted features are ranked and fed to the support vector machine (SVM) and other supervised learning classifiers. In this study, we have considered five different classification problems (CPs), (two-class (CP-1), three-class (CP-2), four-class (CP-3), five-class (CP-4) and six-class (CP-5)). The proposed system yielded accuracies of 98.3%, 93.9%, 92.1%, 91.7%, and 91.5% for CP-1 to CP-5, respectively, using 10-fold cross validation (CV) technique.
  9. Vallonthaiel AG, Walia R, Pramanik R, Sharma MC, Jain D
    Malays J Pathol, 2017 Aug;39(2):175-179.
    PMID: 28866701
    p40, one of the two isomers of p63, is nowadays widely used for diagnosis of squamous cell carcinoma, especially in subtyping non-small cell carcinoma on lung biopsies. We describe a case in which lung tumour was misdiagnosed as squamous cell carcinoma due to p40 immunopositivity. A 36-year-old lady presented with cough and left sided chest pain of 2 months duration. Chest imaging revealed a lesion in left lower lobe of the lung and biopsy was suggestive of squamous cell carcinoma. However, past history revealed amputation of great toe for non-healing discharging ulcer which on histopathology was diagnosed as choriocarcinoma. She also had a history of hysterectomy five years ago, details of which were not available. Post-amputation β-hCG levels were high and she had been treated with multimodality chemotherapy for choriocarcinoma. She had good response to chemotherapy initially, however became resistant later on. Review of the lung biopsy in the light of the past history along with extensive literature review led to the final diagnosis of metastatic trophoblastic tumour to lung. Hence, awareness that p40 immunopositivity can be seen in trophoblastic tumours is essential to avoid misdiagnosis, especially in sites like the lung where squamous cell carcinoma is common.
  10. Mukherjee S, Sharma M, Devgan A, Jatana SK
    Med J Armed Forces India, 2018 Jul;74(3):235-240.
    PMID: 30093766 DOI: 10.1016/j.mjafi.2017.07.003
    Background: Iron deficiency anemia (IDA) in cyanotic congenital heart disease (CCHD) and its association with cyanotic spells has been documented in literature. However, Indian data especially in the pediatric age group is scarce. This study was conducted to find out the prevalence of IDA in this population.

    Methods: An observational study was conducted in a tertiary care hospital. Children with CCHD in the age group of birth-12 years were included in the study. Hematological parameters of these patients were determined and compared. An assessment of the incidence of cyanotic spells in the iron-deficient and iron non-deficient children was also done. Data analysis was done using Fischer's exact test.

    Results: The prevalence of IDA was 47.06% in the study population. The study also showed that hemoglobin and hematocrit levels were paradoxically higher in the iron-deficient group as compared to the non-deficient, though the iron studies revealed the iron deficiency. The incidence of cyanotic spells was higher in the iron-deficient group. The mean corpuscular volume (MCV), red cell distribution width (RDW), serum ferritin, serum iron, total iron binding capacity (TIBC), and transferrin saturation (TS) values were the parameters, which were found to be statistically significant to differentiate the study groups.

    Conclusion: The prevalence of IDA in children with CCHD was found to be high. Iron-deficient group had an increased frequency of cyanotic spells as compared to the non-deficient group, which was statistically significant.

  11. Pannu D, Bharti R, Anand HP, Sharma M
    Malays J Med Sci, 2016 Sep;23(5):96-99.
    PMID: 27904431
    Term, live abdominal pregnancy secondary to rupture of a uterine rudimentary horn is a rare condition. Pregnancies conceived in the rudimentary horn of the uterus usually rupture during early gestation and present as a catastrophic event. However, rarely, after rupture of the uterine horn the foetus may continue to grow in the abdominal cavity and reach term gestation. A primigravida with a term pregnancy was referred to our centre for caesarean section with ultrasonography findings of transverse lie and placenta previa. During surgery, a live baby was extracted from the abdominal cavity, revealing a bicornuate uterus with rupture of the rudimentary horn. The early peroperative diagnosis and prompt control of the bleeding with excision of the rudimentary horn and transfusion of multiple blood products saved the patient's life. The case is presented for its rarity and to highlight the importance of a high index of suspicion in cases presenting with abnormal foetal presentation.
  12. Ray P, Sharma J, Marak RS, Singhi S, Taneja N, Garg RK, et al.
    Indian J. Med. Res., 2004 Dec;120(6):523-6.
    PMID: 15654137
    Though Chromobacterium violaceum is a common inhabitant of soil and water in tropical and sub-tropical regions, human infections are rare but when they do occur result in high mortality. Since the first case from Malaysia in 1927, about 150 cases have been reported in world literature. Till date 6 cases have been reported from southern and eastern parts of India. We report here a case of C. violaceum septicaemia, probably the first case from north India. The patient, a 6 and a half year old boy was admitted with high fever. The patient had anaemia, neutrophilic leucocytosis and bilateral chest infiltrates. Routine and bacteriological investigations were carried out to establish the aetiological diagnosis. C. violaceum was isolated in pure culture from blood and pus. The patient was successfully treated with ciprofloxacin and amikacin. This is probably the first documented case report of C. violaceum infection from north India and the only Indian case with septicaemia which survived.
  13. Ching TY, Quar TK, Johnson EE, Newall P, Sharma M
    J Am Acad Audiol, 2015 Mar;26(3):260-74.
    PMID: 25751694 DOI: 10.3766/jaaa.26.3.6
    BACKGROUND: An important goal of providing amplification to children with hearing loss is to ensure that hearing aids are adjusted to match targets of prescriptive procedures as closely as possible. The Desired Sensation Level (DSL) v5 and the National Acoustic Laboratories' prescription for nonlinear hearing aids, version 1 (NAL-NL1) procedures are widely used in fitting hearing aids to children. Little is known about hearing aid fitting outcomes for children with severe or profound hearing loss.

    PURPOSE: The purpose of this study was to investigate the prescribed and measured gain of hearing aids fit according to the NAL-NL1 and the DSL v5 procedure for children with moderately severe to profound hearing loss; and to examine the impact of choice of prescription on predicted speech intelligibility and loudness.

    RESEARCH DESIGN: Participants were fit with Phonak Naida V SP hearing aids according to the NAL-NL1 and DSL v5 procedures. The Speech Intelligibility Index (SII) and estimated loudness were calculated using published models.

    STUDY SAMPLE: The sample consisted of 16 children (30 ears) aged between 7 and 17 yr old.

    DATA COLLECTION AND ANALYSIS: The measured hearing aid gains were compared with the prescribed gains at 50 (low), 65 (medium), and 80 dB SPL (high) input levels. The goodness of fit-to-targets was quantified by calculating the average root-mean-square (RMS) error of the measured gain compared with prescriptive gain targets for 0.5, 1, 2, and 4 kHz. The significance of difference between prescriptions for hearing aid gains, SII, and loudness was examined by performing analyses of variance. Correlation analyses were used to examine the relationship between measures.

    RESULTS: The DSL v5 prescribed significantly higher overall gain than the NAL-NL1 procedure for the same audiograms. For low and medium input levels, the hearing aids of all children fit with NAL-NL1 were within 5 dB RMS of prescribed targets, but 33% (10 ears) deviated from the DSL v5 targets by more than 5 dB RMS on average. For high input level, the hearing aid fittings of 60% and 43% of ears deviated by more than 5 dB RMS from targets of NAL-NL1 and DSL v5, respectively. Greater deviations from targets were associated with more severe hearing loss. On average, the SII was higher for DSL v5 than for NAL-NL1 at low input level. No significant difference in SII was found between prescriptions at medium or high input level, despite greater loudness for DSL v5 than for NAL-NL1.

    CONCLUSIONS: Although targets between 0.25 and 2 kHz were well matched for both prescriptions in commercial hearing aids, gain targets at 4 kHz were matched for NAL-NL1 only. Although the two prescriptions differ markedly in estimated loudness, they resulted in comparable predicted speech intelligibility for medium and high input levels.

  14. Gorajana A, Ying CC, Shuang Y, Fong P, Tan Z, Gupta J, et al.
    Curr Drug Deliv, 2013 Jun;10(3):309-16.
    PMID: 23360246
    Dapivirine, formerly known as TMC 120, is a poorly-water soluble anti-HIV drug, currently being developed as a vaginal microbicide. The clinical use of this drug has been limited due to its poor solubility. The aim of this study was to design solid dispersion systems of Dapivirine to improve its solubility. Solid dispersions were prepared by solvent and fusion methods. Dapivirine release from the solid dispersion system was determined by conducting in-vitro dissolution studies. The physicochemical characteristics of the drug and its formulation were studied using Differential Scanning Calorimetry (DSC), powder X-ray Diffraction (XRD), Fourier-transform Infrared Spectroscopy (FTIR) and Scanning Electron Microscopy (SEM). A significant improvement in drug dissolution rate was observed with the solid dispersion systems. XRD, SEM and DSC results indicated the transformation of pure Dapivirine which exists in crystalline form into an amorphous form in selected solid dispersion formulations. FTIR and HPLC analysis confirmed the absence of drug-excipient interactions. Solid dispersion systems can be used to improve the dissolution rate of Dapivirine. This improvement could be attributed to the reduction or absence of drug crystallinity, existence of drug particles in an amorphous form and improved wettability of the drug.
  15. Singh R, Tan SG, Panandam JM, Rahman RA, Ooi LC, Low ET, et al.
    BMC Plant Biol., 2009;9:114.
    PMID: 19706196 DOI: 10.1186/1471-2229-9-114
    Marker Assisted Selection (MAS) is well suited to a perennial crop like oil palm, in which the economic products are not produced until several years after planting. The use of DNA markers for selection in such crops can greatly reduce the number of breeding cycles needed. With the use of DNA markers, informed decisions can be made at the nursery stage, regarding which individuals should be retained as breeding stock, which are satisfactory for agricultural production, and which should be culled. The trait associated with oil quality, measured in terms of its fatty acid composition, is an important agronomic trait that can eventually be tracked using molecular markers. This will speed up the production of new and improved oil palm planting materials.
  16. Saunders JB, Hao W, Long J, King DL, Mann K, Fauth-Bühler M, et al.
    J Behav Addict, 2017 Sep 01;6(3):271-279.
    PMID: 28816494 DOI: 10.1556/2006.6.2017.039
    Online gaming has greatly increased in popularity in recent years, and with this has come a multiplicity of problems due to excessive involvement in gaming. Gaming disorder, both online and offline, has been defined for the first time in the draft of 11th revision of the International Classification of Diseases (ICD-11). National surveys have shown prevalence rates of gaming disorder/addiction of 10%-15% among young people in several Asian countries and of 1%-10% in their counterparts in some Western countries. Several diseases related to excessive gaming are now recognized, and clinics are being established to respond to individual, family, and community concerns, but many cases remain hidden. Gaming disorder shares many features with addictions due to psychoactive substances and with gambling disorder, and functional neuroimaging shows that similar areas of the brain are activated. Governments and health agencies worldwide are seeking for the effects of online gaming to be addressed, and for preventive approaches to be developed. Central to this effort is a need to delineate the nature of the problem, which is the purpose of the definitions in the draft of ICD-11.
  17. Choudhury A, Jindal A, Maiwall R, Sharma MK, Sharma BC, Pamecha V, et al.
    Hepatol Int, 2017 Sep;11(5):461-471.
    PMID: 28856540 DOI: 10.1007/s12072-017-9816-z
    BACKGROUND AND AIMS: Acute-on-chronic liver failure (ACLF) is a progressive disease associated with rapid clinical worsening and high mortality. Early prediction of mortality and intervention can improve patient outcomes. We aimed to develop a dynamic prognostic model and compare it with the existing models.

    METHODS: A total of 1402 ACLF patients, enrolled in the APASL-ACLF Research Consortium (AARC) with 90-day follow-up, were analyzed. An ACLF score was developed in a derivation cohort (n = 480) and was validated (n = 922).

    RESULTS: The overall survival of ACLF patients at 28 days was 51.7%, with a median of 26.3 days. Five baseline variables, total bilirubin, creatinine, serum lactate, INR and hepatic encephalopathy, were found to be independent predictors of mortality, with AUROC in derivation and validation cohorts being 0.80 and 0.78, respectively. AARC-ACLF score (range 5-15) was found to be superior to MELD and CLIF SOFA scores in predicting mortality with an AUROC of 0.80. The point scores were categorized into grades of liver failure (Gr I: 5-7; II: 8-10; and III: 11-15 points) with 28-day cumulative mortalities of 12.7, 44.5 and 85.9%, respectively. The mortality risk could be dynamically calculated as, with each unit increase in AARC-ACLF score above 10, the risk increased by 20%. A score of ≥11 at baseline or persisting in the first week was often seen among nonsurvivors (p = 0.001).

    CONCLUSIONS: The AARC-ACLF score is easy to use, dynamic and reliable, and superior to the existing prediction models. It can reliably predict the need for interventions, such as liver transplant, within the first week.

  18. Schaefer N, Rotermund C, Blumrich EM, Lourenco MV, Joshi P, Hegemann RU, et al.
    J. Neurochem., 2017 Jun 20.
    PMID: 28632905 DOI: 10.1111/jnc.14107
    One of the most intriguing features of the brain is its ability to be malleable, allowing it to adapt continually to changes in the environment. Specific neuronal activity patterns drive long-lasting increases or decreases in the strength of synaptic connections, referred to as long-term potentiation and long-term depression, respectively. Such phenomena have been described in a variety of model organisms, which are used to study molecular, structural, and functional aspects of synaptic plasticity. This review originated from the first International Society for Neurochemistry (ISN) and Journal of Neurochemistry (JNC) Flagship School held in Alpbach, Austria (Sep 2016), and will use its curriculum and discussions as a framework to review some of the current knowledge in the field of synaptic plasticity. First, we describe the role of plasticity during development and the persistent changes of neural circuitry occurring when sensory input is altered during critical developmental stages. We then outline the signaling cascades resulting in the synthesis of new plasticity-related proteins, which ultimately enable sustained changes in synaptic strength. Going beyond the traditional understanding of synaptic plasticity conceptualized by long-term potentiation and long-term depression, we discuss system-wide modifications and recently unveiled homeostatic mechanisms, such as synaptic scaling. Finally, we describe the neural circuits and synaptic plasticity mechanisms driving associative memory and motor learning. Evidence summarized in this review provides a current view of synaptic plasticity in its various forms, offers new insights into the underlying mechanisms and behavioral relevance, and provides directions for future research in the field of synaptic plasticity. Read the Editorial Highlight for this article on doi: 10.1111/jnc.14102.
  19. Mrkobrada M, Chan MTV, Cowan D, Spence J, Campbell D, Wang CY, et al.
    BMJ Open, 2018 07 06;8(7):e021521.
    PMID: 29982215 DOI: 10.1136/bmjopen-2018-021521
    OBJECTIVES: Covert stroke after non-cardiac surgery may have substantial impact on duration and quality of life. In non-surgical patients, covert stroke is more common than overt stroke and is associated with an increased risk of cognitive decline and dementia. Little is known about covert stroke after non-cardiac surgery.NeuroVISION is a multicentre, international, prospective cohort study that will characterise the association between perioperative acute covert stroke and postoperative cognitive function.

    SETTING AND PARTICIPANTS: We are recruiting study participants from 12 tertiary care hospitals in 10 countries on 5 continents.

    PARTICIPANTS: We are enrolling patients ≥65 years of age, requiring hospital admission after non-cardiac surgery, who have an anticipated length of hospital stay of at least 2 days after elective non-cardiac surgery that occurs under general or neuraxial anaesthesia.

    PRIMARY AND SECONDARY OUTCOME MEASURES: Patients are recruited before elective non-cardiac surgery, and their cognitive function is measured using the Montreal Cognitive Assessment (MoCA) instrument. After surgery, a brain MRI study is performed between postoperative days 2 and 9 to determine the presence of acute brain infarction. One year after surgery, the MoCA is used to assess postoperative cognitive function. Physicians and patients are blinded to the MRI study results until after the last patient follow-up visit to reduce outcome ascertainment bias.We will undertake a multivariable logistic regression analysis in which the dependent variable is the change in cognitive function 1 year after surgery, and the independent variables are acute perioperative covert stroke as well as other clinical variables that are associated with cognitive dysfunction.

    CONCLUSIONS: The NeuroVISION study will characterise the epidemiology of covert stroke and its clinical consequences. This will be the largest and the most comprehensive study of perioperative stroke after non-cardiac surgery.

    TRIAL REGISTRATION NUMBER: NCT01980511; Pre-results.

  20. Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, et al.
    Can J Cardiol, 2017 08;33(8):1027-1035.
    PMID: 28754388 DOI: 10.1016/j.cjca.2017.06.001
    BACKGROUND: Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban as well as aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor therapy.

    METHODS: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) is a double-blind superiority trial comparing rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily or rivaroxaban 5 mg twice daily vs aspirin 100 mg once daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a proton pump inhibitor were also randomized, using a partial factorial design, to pantoprazole 40 mg once daily or placebo. The trial was designed to have at least 90% power to detect a 20% reduction in each of the rivaroxaban treatment arms compared with aspirin and to detect a 50% reduction in upper GI complications with pantoprazole compared with placebo.

    RESULTS: Between February 2013 and May 2016, we recruited 27,395 participants from 602 centres in 33 countries; 17,598 participants were included in the pantoprazole vs placebo comparison. At baseline, the mean age was 68.2 years, 22.0% were female, 90.6% had CAD, and 27.3% had PAD.

    CONCLUSIONS: COMPASS will provide information on the efficacy and safety of rivaroxaban, alone or in combination with aspirin, in the long-term management of patients with stable CAD or PAD, and on the efficacy and safety of pantoprazole in preventing upper GI complications in patients receiving antithrombotic therapy.

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