Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-01 @ 3:27 AM
Study NCT ID:
NCT04524234
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2020-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Dysfunction in Critically Ill Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'All cause death in patients with vs without cardiac dysfunction'}], 'secondaryOutcomes': [{'measure': 'Left ventricular dysfunction', 'timeFrame': 'Within 72 hours from admission', 'description': 'Prevalence of left ventricular dysfunction'}, {'measure': 'Right ventricular dysfunction', 'timeFrame': 'Within 72 hours from admission', 'description': 'Prevalence of right ventricular dysfunction'}, {'measure': 'Risk-factors', 'timeFrame': 'Within 72 hours from admission', 'description': 'Clinical variables associated with risk of having cardiac dysfunction'}, {'measure': 'Cardiac biomarkers', 'timeFrame': 'Within 72 hours from admission', 'description': 'Levels of cardiac biomarkers in patients with vs without cardiac dysfunction'}, {'measure': 'Left ventricular dysfunction', 'timeFrame': 'During ICU-stay', 'description': 'Prevalence of left ventricular dysfunction'}, {'measure': 'Right ventricular dysfunction', 'timeFrame': 'During ICU-stay', 'description': 'Prevalence of right ventricular dysfunction'}, {'measure': 'Risk-factors', 'timeFrame': 'During ICU-stay', 'description': 'Clinical variables associated with risk of having cardiac dysfunction'}, {'measure': 'Cardiac biomarkers', 'timeFrame': 'During ICU-stay', 'description': 'Levels of cardiac biomarkers in patients with vs without cardiac dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Left Ventricular Dysfunction', 'Right Ventricular Dysfunction', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients infected with COVID-19.', 'detailedDescription': 'Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients with COVID-19. Patients admitted to the intensive care unit, with COVID-19 are examined with echocardiography for assessment of left and right ventricular dysfunction within 72 hours from admission and repeated after four to seven days.\n\nCardiac dysfunction was defined as having either left ventricular (LV) dysfunction, defined as having an ejection fraction \\<50% and/or regional hypokinesia, or right ventricular (RV) dysfunction, defined as having a tricuspid annular plane excursion (TAPSE) \\<17mm or a moderate/severe RV dysfunction assessed visually.\n\nThe cardiac biomarkers troponin and NTproBNP and clinical data are recorded at time of each echo. Mortality status is recorded at 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion', 'eligibilityCriteria': 'Inclusion Criteria: Patients admitted to the intensive care unit infected with COVID-19\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04524234', 'acronym': 'CARDYCOVID', 'briefTitle': 'Cardiac Dysfunction in Critically Ill Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Cardiac Dysfunction in Critically Ill Patients With COVID-19', 'orgStudyIdInfo': {'id': 'CARDY CRIT COVID'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Echocardiography for assessment of cardiac function'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'state': 'Region Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '40530', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital/Mölndal', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '40530', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital/Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '41345', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Trollhättan', 'state': 'Västra Götalandsregionen', 'country': 'Sweden', 'facility': 'North Älvsborg County Hospital', 'geoPoint': {'lat': 58.28365, 'lon': 12.28864}}], 'overallOfficials': [{'name': 'Jonatan Oras, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jonatan Oras', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}