COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

NCT ID: NCT04661657

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2022-01-22

Brief Summary

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.

Detailed Description

This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.

CMR 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.

Transthoracic 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.

Conditions

Covid19; Cardiac Disease; Cardiac Arrhythmia; Myocarditis; Left Ventricular Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19

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).

Transthoracic echocardiogram (TTE)

Intervention Type: OTHER

Subjects will undergo TTE imaging.

Cardiovascular Magnetic Resonance (CMR) Imaging

Intervention Type: OTHER

Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).

Control

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).

Transthoracic echocardiogram (TTE)

Intervention Type: OTHER

Subjects will undergo TTE imaging.

Cardiovascular Magnetic Resonance (CMR) Imaging

Intervention Type: OTHER

Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).

Interventions

Transthoracic echocardiogram (TTE)

Subjects will undergo TTE imaging.

Intervention Type: OTHER

Cardiovascular Magnetic Resonance (CMR) Imaging

Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Convalescent COVID-19 patient
• If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.
• Control patients who have had a negative COVID-19 screening without prior positive tests.
• Willingness to undergo Clariscan-enhanced CMR scan.
• Ability to hold breath for 15 seconds.
• Willingness to give informed consent.
• Greater than or equal to 18 years of Age.

Exclusion Criteria

• Subjects who are Pregnant or nursing
• Severe valvular heart disease
• History of congestive heart failure preceding COVID-19
• History of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8
• Contraindication to MRI
• Known allergy to gadoterate
• Estimated glomerular filtration rate <30 ml/min/1.73m2
• History of receiving more than 2 doses of a gadolinium-based contrast agent
• Subject is of prisoner status

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew J. Einstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia Univeristy

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAT0787

Identifier Type: -

Identifier Source: org_study_id