Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 7:17 PM
Study NCT ID:
NCT04624503
Status:
UNKNOWN
Last Update Posted:
2020-11-10
First Post:
2020-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-10-17', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '1 month', 'description': 'Mortality due to cardiovascular causes at 1 month after hospitalization'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '6 months', 'description': 'Mortality due to cardiovascular causes at 6 months after hospitalization'}, {'measure': 'All-cause mortality', 'timeFrame': '1 month', 'description': 'Mortality due to all causes at 1 month after hospitalization'}, {'measure': 'All-cause mortality', 'timeFrame': '6 months', 'description': 'Mortality due to all causes at 6 months after hospitalization'}, {'measure': 'Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)', 'timeFrame': '1 month', 'description': 'Major adverse cardiovascular events at 1 month after hospitalization'}, {'measure': 'Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)', 'timeFrame': '6 months', 'description': 'Major adverse cardiovascular events at 6 months after hospitalization'}], 'secondaryOutcomes': [{'measure': 'NYHA class', 'timeFrame': '6 months', 'description': 'NYHA functional class: from I (no limitation of physical activity) to IV (severe limitation with symptoms at rest)'}, {'measure': 'Left ventricular systolic function (cardiac magnetic resonance, echocardiography)', 'timeFrame': '6 months', 'description': 'Left ventricular systolic function evaluated with multimodality imaging'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular involvement', 'COVID-19'], 'conditions': ['Covid19', 'Myocardial Injury', 'Cardiovascular Diseases', 'Heart Failure', 'Cardiovascular Morbidity']}, 'referencesModule': {'references': [{'pmid': '32817312', 'type': 'RESULT', 'citation': 'Stefanini GG, Chiarito M, Ferrante G, Cannata F, Azzolini E, Viggiani G, De Marco A, Briani M, Bocciolone M, Bragato R, Corrada E, Gasparini GL, Marconi M, Monti L, Pagnotta PA, Panico C, Pini D, Regazzoli D, My I, Kallikourdis M, Ciccarelli M, Badalamenti S, Aghemo A, Reimers B, Condorelli G; Humanitas COVID-19 Task Force. Early detection of elevated cardiac biomarkers to optimise risk stratification in patients with COVID-19. Heart. 2020 Oct;106(19):1512-1518. doi: 10.1136/heartjnl-2020-317322. Epub 2020 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.\n\nOn this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients.', 'detailedDescription': 'COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.\n\nOn this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients, with a 1-month and 6-month follow-up composed of clinical evaluation, electrocardiogram, trans-thoracic echocardiogram, cardiovascular magnetic resonance, chest computerized tomography scan and cardiopulmonary exercise test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients for COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients who were hospitalized for COVID-19\n\nExclusion Criteria: None.'}, 'identificationModule': {'nctId': 'NCT04624503', 'acronym': 'CARDIO-COVID', 'briefTitle': 'Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Hospital, Italy'}, 'officialTitle': 'Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19 (Rilevanza Clinica e Prognostica Del Coinvolgimento Cardiovascolare Nei Pazienti Affetti da COVID-19)', 'orgStudyIdInfo': {'id': 'CARDIOCOVID'}}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulio Stefanini, Prof', 'role': 'CONTACT', 'email': 'giulio.stefanini@hunimed.eu', 'phone': '0282247384'}, {'name': 'Gianluigi Condorelli, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giulio Stefanini, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piergiuseppe Agostoni, Prof.', 'role': 'CONTACT'}], 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Badano, Prof.', 'role': 'CONTACT'}], 'facility': 'IRCCS Auxologico San Luca', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Guazzi, Prof', 'role': 'CONTACT'}], 'facility': 'IRCCS San Donato', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sivlia Priori, Prof.ssa', 'role': 'CONTACT'}], 'facility': 'IRCCS Istituti Clinici Scientifici Maugeri', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giulio Stefanini, Prof.', 'role': 'CONTACT', 'email': 'giulio.stefanini@hunimed.eu', 'phone': '0282247384'}], 'overallOfficials': [{'name': 'Gianluigi Condorelli, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Hospital, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Giulio Stefanini', 'investigatorAffiliation': 'Humanitas Hospital, Italy'}}}}