Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT04438993
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2020-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The COVID-19 Disease and CARdiac Events Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Venous blood plasma retained for future analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac abnormalities in COVID-19 disease in-patients', 'timeFrame': '6 months', 'description': 'The primary objective of this study is to characterise the prevalence of myocardial injury and cardiac dysfunction in patients hospitalised with COVID-19 disease.'}], 'secondaryOutcomes': [{'measure': 'Biomarker - hsTnT', 'timeFrame': '30 days', 'description': 'To compare levels of hsTnT in ng/L between patients who experience an adverse event and those who do not.'}, {'measure': 'Biomarker - NT-proBNP', 'timeFrame': '30 days', 'description': 'To compare levels of NT-proBNP in pg/ml between patients who experience an adverse event and those who do not.'}, {'measure': 'Biomarker - ferritin', 'timeFrame': '30 days', 'description': 'To compare levels of ferritin in ug/L between patients who experience an adverse event and those who do not.'}, {'measure': 'Biomarker - cytokines', 'timeFrame': '30 days', 'description': 'To compare levels of cytokines in pg/mL between patients who experience an adverse event and those who do not.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Echocardiogram', 'Troponin', 'NT-proBNP', 'Cytokines'], 'conditions': ['COVID', 'Coronavirus']}, 'descriptionModule': {'briefSummary': 'An observational study of consecutive patients testing positive for COVID-19 who require admission to hospital to determine the degree of myocardial injury through biomarkers and echocardiography and the impact of this on cardiovascular outcomes. The COVID-19 disease and CARdiac Events study (COVICARE).', 'detailedDescription': 'Purposes:\n\n1. To determine the prevalence of myocardial injury/impairment in patients hospitalised with COVID-19 disease.\n2. To determine the predictive value of baseline biomarkers in identifying patients at high risk of significant morbidity/mortality due to COVID-19.\n\nJustification:\n\nThe Novel Coronavirus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), first recorded in Hubei Province of Wuhan China in December 2019 has now swept the globe and has been declared a pandemic by the World Health Organisation.\n\nThe largest published registry from the Chinese centre for disease control and prevention (CDC) describes a disease with a broad range of acuity but found from a cohort of 72314 confirmed or suspected cases (72314) 14% of those affected required hospitalisation and 5% required critical care. Thus far treatment has focused on quarantine and supportive care.\n\nPredicting outcomes in COVID disease requires risk stratifying infected patients. Data so far have mainly come from small studies in China but the consistent risk factors appear to be advanced age, diabetes, hypertension and cardiovascular disease. The CDC report a 10.5% risk of death associated with underlying cardiovascular disease, surprisingly more than those with respiratory disease, especially given that lung involvement is the dominant clinical presentation. The reason for poor outcome in cardiovascular disease is unknown but is likely to be multifactorial. A literature search of nine observational studies reported myocardial injury based on high sensitivity troponin, abnormal ECG, abnormal echocardiogram or a combination of the three. The reported rate of myocardial injury ranged from 7-28% and in all groups was associated with higher rates of requirement for critical care. Mortality was increased compared to those without myocardial injury- 51.2% vs 4.5%.\n\nTrial overview:\n\nPatients admitted to University Hospital Hairmyres (UHH) with confirmed COVID-19 will have 3 biomarkers - high sensitivity troponin T (hsTnT), N-terminal (NT)-proBNP and ferritin - added on retrospectively to their admission blood samples, and an additional sample will be taken for cytokine analysis.\n\nAn ECG and echocardiogram will be performed.\n\nPatients will be observed during the remainder of the hospitalisation and for up to 30 days from admission for major adverse cardiac events.\n\nStatistical analysis:\n\nThe prevalence of echocardiographic abnormalities in the cohort will be presented.\n\nBiomarker levels will be compared between patients who require intensive treatment unit (ITU) admission or not, ventilation or not or who die or survive up to 30 days using independent samples t-tests if the data are normally distributed or Mann-Whitney-U tests if non normally distributed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "We plan to enrol all consecutive admissions with COVID-19 disease admitted to UHH up until a maximal target of 100 patients have been recruited. Patients will have a positive real time reverse transcription (rt)PCR for SARS-CoV-2 nasopharyngeal swab and/or chest X-ray or CT imaging showing classical COVID-19 disease abnormalities ('classic/probable COVID-19, mild/mod or severe' according to current British Society of Thoracic Imaging guidance, and be within 5 days of admission (so as to enable us to retrospectively add on biomarkers to blood samples sent on admission to hospital).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. In-patient in UHH within first 5 days of admission\n3. COVID-19 disease confirmed on rtPCR detection of SARS-CoV-2 from nasopharyngeal swabs and/or thoracic X-ray imaging findings characteristic of COVID-19 disease (positive swab results preferred).\n4. Able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Refusal of consent for enrolment.\n2. Known pre-existing left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \\<40%.'}, 'identificationModule': {'nctId': 'NCT04438993', 'acronym': 'COVICARE', 'briefTitle': 'The COVID-19 Disease and CARdiac Events Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Lanarkshire'}, 'officialTitle': 'An Observational Study of Hospitalised Patients With Coronavirus Disease 2019 (COVID-19) to Determine the Degree of Myocardial Injury Using Biomarkers and Echocardiography, and the Impact of This on Cardiovascular Outcomes', 'orgStudyIdInfo': {'id': 'COVI-RW-2020'}}, 'contactsLocationsModule': {'locations': [{'zip': 'G75 8RG', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University Hospital Hairmyres', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Robin A Weir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lanarkshire'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Lanarkshire', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}