[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523421":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cirrhotic cardiomyopathy",null,"Cirrhotic cardiomyopathy, among a broad spectrum of cardiac complications in cirrhosis, is characterized by systolic and diastolic cardiac dysfunction and electrocardiographic changes. However, it is seen more in NASH related cirrhotic patients, who have an additional risk of developing cardiac complications. Cirrhosis contributes to a including cirrhotic cardiomyopathy owing to various pathological conditions interlinked at the cellular and molecular level. A hyperdynamic circulatory state caused due to excessive release of vasodilators in a pro-inflammatory condition of cirrhosis, along with negative-inotropic pathways contributes to the development of a compromised cardiac function. Electrocardiography, 2D echocardiography with tissue Doppler or speckle tracking are the routine diagnostic tests used to diagnose CCM.",[13,14],"Device: Echocardiographic assessment","Diagnostic Test: Histopathology and Immunohistochemistry",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DEVICE","Echocardiographic assessment","M mode, cross sectional and pulsed wave Doppler Echocardiographic examinations will be performed using a with a 2.5 MHz wide angle phased array transducer. Patients will be laid in left lateral position and examined in standard parasternal long and short axis and apical views. Short axis recordings will be performed at the level of the papillary muscles. M mode tracings will be recorded at the level of the papillary muscles and the aortic valves, with 2 -D guidance. LV wall thickness and cavity diameters will be measured by M mode, through the largest diameter of the ventricle, if possible, both in diastole and systole. Using the cross-sectional images as a guide, the M mode tracing of the left ventricle will obtained to calculate measurements according to the recommendations of American Society of Echocardiography.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Histopathology and Immunohistochemistry","In patients who do not survive, we will take a trucut core biopsy from the ventricular myocardium, using ultrasound guidance. Cardiac tissue slices preserve the heterogeneous structure and multicellularity of the myocardium and allow its functional characterization. However, in this protocol, only those patients who consent to autopsy or those who consent to most mortem biopsy will be sampled for cardiac histology in CCM. Thus samples for histology and immunohistopathology will be available in only a few patients.\n\nFor the immunohistochemistry study, the sections will be collected on the poly-L-lysine covered slides and dried in a thermostat, at 37°C, for 24 hours, for increasing the adherence of the biological material to the histological slide.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Madhumita Premkumar","CONTACT","01722754777","drmadhumitap@gmail.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":10,"geoPoint":10,"contacts":41},"Dr. Madhumita Premkumar","RECRUITING","Sector-12","Chandigarh","160012","India","IN",[42],{"name":43,"role":29,"phone":10,"phoneExt":10,"email":31},"Dr. Madhumita Premkumar, MD",{"type":45,"investigatorFullName":28,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Associate Professor","100523421","cirrhotic-cardiomyopathy-based-on-point-of-care-echocardiography-biomarkers-and-histology-100523421",false,"NCT06095466","Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Inclusion Criteria:\n\n* Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following:\n\n  * Age range of 18-65 years\n  * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Valvular heart disease\n* Sick sinus syndrome\u002F Pacemaker\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males at the time of assessment","ALL","18 Years","65 Years",{"count":58,"type":59},150,"ESTIMATED","OBSERVATIONAL","Cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E\u002Fe' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre.",[63,64,65],"Cirrhotic Cardiomyopathy","Cirrhosis, Liver","Cardiac Disease","2023-10-18",{"date":68,"type":69},"2023-10-23","ACTUAL",{"date":71,"type":69},"2023-07-15",{"date":73,"type":59},"2026-10-15",{"name":5,"class":6},1]