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Study record managers: refer to the Data Element Definitions if submitting registration or information. Our study will clarify the pathogenesis of cardiopulmonary injury, notably endotypes of myocardial injury including myocarditis, in patients with COVID The study involves a prospective, observational, multicentre, longitudinal cohort de.
The investigators aim to minimise selection bias by adopting consecutive screening of all-comers hospitalised with COVID and the eligibility criteria are broad. For example, severe renal dysfunction is not an exclusion criterion. The sample size is patients enrolled at baseline with attending for the primary outcome evaluation cardiac imaging at 28 days post-discharge.
The investigators will use advanced cardiovascular imaging to identify the proportion of patients with myocardial inflammation myocarditis that is sub-clinical i. Cardiovascular MRI and CT coronary angiography will provide a comprehensive examination one month after discharge is intended to detect persisting cardiovascular complications and diagnose clinical endotypes. The investigators aim to clarify the pathological ificance of serial changes in circulating troponin, NTproBNP and renal function. Correlation of imaging findings with baseline clinical information, biomarkers, Sexual chat at the Renfrewshire fitness 19 reported outcome measures and well-being in the longer term will help to clarify the clinical ificance of cardiovascular complications in COVID Since the de is observational, an interim analysis may be undertaken with the timing informed by the enrolment rate.
The endotypes of myocardial injury are 1 myocardial inflammation due to 1.
The final diagnosis will be a consensus-based determination by an expert panel. This information will provide insights into the incidence, nature, time-course and clinical ificance of cardiovascular involvement in patients with COVID The clinical ificance of our findings will be assessed through associations with patient reported outcome measures PROMS and health outcomes in the longer term.
The primary cardio-pulmonary outcome is the proportion of patients with thrombosis [ Time Frame: 28 days after discharge from hospital ] Thrombosis of the right heart, pulmonary arteries and left heart will be determined contrast-enhanced CT chest, angiography and MRI. Other measures of haemostasis will also be measured. Other measures of coagulation will also be measured. Renal function [ Time Frame: 28 days after discharge from hospital ] Assess renal function using urine albumin:creatinine ratio and its change over time.
Association of the primary outcome according to a prior history of cardiovascular disease or no history of prior cardiovascular disease. Other measures of health status will also be assessed.
The outcome is endothelial function in of isolated arterioles from gluteal biopsy. Other measures of vascular function will also be assessed. Cardiovascular science - mathematical modelling [ Time Frame: 1 year ] Exploratory study to help better understand the cardiac biomechanical implications of COVID The outcome measure will be myocardial stiffness Cauchy stress, kPa.
The sub-studies will involve using mathematical modelling and, relatedly, statistical emulation. Health outcomes serious adverse events [ Time Frame: 20 years ] Health outcomes as measured by the occurrence of serious adverse events SAE quantified by 1 rehospitalisation and 2 death.
These events will be identified in the longer term using electronic record linkage to health records held by government and the National Health Service. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study.
Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : August 6, See Contacts and Locations.
Study Description. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID infection in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys. Detailed Description:. FDA Resources. Outcome Measures. Primary Outcome Measures : The primary cardiac outcome is the proportion of patients with a diagnosis of myocardial inflammation myocarditis.
Thrombosis of the right heart, pulmonary arteries and left heart will be determined contrast-enhanced CT chest, angiography and MRI. Assess renal function using urine albumin:creatinine ratio and its change over time.
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Imaging for coronary disease, PTE and lung pathology will be correlated with NHS clinical data on prior history of cardiovascular disease. Health outcomes as measured by the occurrence of serious adverse events SAE quantified by 1 rehospitalisation and 2 death. Samples will be stored for biomarker analyses including DNA.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
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All-comers who have attended or admitted to hospital for COVID and meet the eligibility criteria described. Inclusion Criteria: History of hospital attendance or hospitalisation for COVID, confirmed by a clinical diagnosis, laboratory test e. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. CRF ggc. More Information. COVID and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. Eur Heart J Cardiovasc Imaging. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases.
Eur Heart J. Epub Jul 3. J Am Coll Cardiol. Fourth Universal Definition of Myocardial Infarction Erratum in: Circulation. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Study Type :.
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Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. May 27, Key Record Dates.