Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-04-25 @ 12:13 AM
Study NCT ID:
NCT04661657
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D009205', 'term': 'Myocarditis'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], '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': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of myocardium demonstrating late gadolinium enhancement', 'timeFrame': 'Up to 2 hours', 'description': 'Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.'}, {'measure': 'Extracellular Volume (ECV) Fraction', 'timeFrame': 'Up to 2 hours', 'description': 'Extracellular volume fraction measured by CMR imaging. ECV determined using Circle cvi42 software and using formula ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)).'}, {'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': 'Up to 2 hours', 'description': 'Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Cardiac Disease', 'Cardiac Arrhythmia', 'Myocarditis', 'Left Ventricular Dysfunction']}, 'descriptionModule': {'briefSummary': 'COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.', 'detailedDescription': "This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.\n\nCMR offers the unique ability to comprehensively characterize myocardial tissue and assess the heart's structure and function, through a variety of complementary imaging techniques using different pulse sequences. The investigators propose to provide a multi-sequence CMR evaluation of a spectrum of convalescent COVID-19 patients, compare COVID-19 survivors to controls, and study the relationships between myocardial characteristics by CMR and echocardiography and health outcomes, and how these are modulated through patient characteristics, and clinical characteristics of COVID-19 illness. Broadly, this myocardial characterization will not just provide diagnosis but serve as a potentially powerful tool for risk stratification, therapeutic decision making, and monitoring response to therapies in COVID-19 survivors.\n\nTransthoracic echocardiography (TTE) is the most widely used imaging technique for the assessment of cardiac morphology and function. While its capability for myocardial tissue characterization is inferior to that of CMR, TTE provides several advantages that make it an ideal complement to CMR for the assessment of cardiac involvement in COVID-19 patients. TTE offers a rapid noninvasive evaluation of myocardial and valvular function, in addition to the assessment of other cardiac abnormalities of interest (such as presence and amount of pericardial effusion) and important hemodynamic variables (noninvasive estimation of pulmonary pressures is an example). TTE is easily performed and reproducible, and does not involve the use of radiations or contrast agents, which allows the performance of repeat evaluations to assess serial changes over time in the cardiac parameters of interest."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 18 years of age or older, without cardiac disease who have tested positive for COVID-19 or healthy control subjects who have not had COVID-19. Willing to undergo Cardiac MRI and Transthoracic echocardiogram. No known sensitivity to Gadolinium based contrast agent.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Convalescent COVID-19 patient\n* If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.\n* Control patients who have had a negative COVID-19 screening without prior positive tests.\n* Willingness to undergo Clariscan-enhanced CMR scan.\n* Ability to hold breath for 15 seconds.\n* Willingness to give informed consent.\n* Greater than or equal to 18 years of Age.\n\nExclusion Criteria:\n\n* Subjects who are Pregnant or nursing\n* Severe valvular heart disease\n* History of congestive heart failure preceding COVID-19\n* History of obstructive coronary artery disease with known stenosis \\>70% or fractional flow reserve \\< 0.8\n* Contraindication to MRI\n* Known allergy to gadoterate\n* Estimated glomerular filtration rate \\<30 ml/min/1.73m2\n* History of receiving more than 2 doses of a gadolinium-based contrast agent\n* Subject is of prisoner status'}, 'identificationModule': {'nctId': 'NCT04661657', 'briefTitle': 'COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry', 'orgStudyIdInfo': {'id': 'AAAT0787'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19', 'description': 'Non-prisoner and non-pregnant subjects, without prior cardiac disease, who have tested positive or have been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA).', 'interventionNames': ['Other: Transthoracic echocardiogram (TTE)', 'Other: Cardiovascular Magnetic Resonance (CMR) Imaging']}, {'label': 'Control', 'description': 'Non-prisoner and non-pregnant subjects, without prior cardiac disease, who have never tested positive and/or has never been hospitalized due to COVID-19 infection. Subjects will be undergo a physical exam, blood draw to asses serological biomarkers. Subjects will also undergo an transthoracic echocardiogram (TTE) and a clariscan-enhanced cardiovascular magnetic resonance imaging (CMR) using a gadolinium based contrast agent (GBCA).', 'interventionNames': ['Other: Transthoracic echocardiogram (TTE)', 'Other: Cardiovascular Magnetic Resonance (CMR) Imaging']}], 'interventions': [{'name': 'Transthoracic echocardiogram (TTE)', 'type': 'OTHER', 'description': 'Subjects will undergo TTE imaging.', 'armGroupLabels': ['COVID-19', 'Control']}, {'name': 'Cardiovascular Magnetic Resonance (CMR) Imaging', 'type': 'OTHER', 'description': 'Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).', 'armGroupLabels': ['COVID-19', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrew J. Einstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}