Official Title
COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
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.

Completed
COVID19
Cardiac Disease
Cardiac Arrhythmia
Myocarditis
Left Ventricular Dysfunction

Other: Transthoracic echocardiogram (TTE)

Subjects will undergo TTE imaging.

Other: Cardiovascular Magnetic Resonance (CMR) Imaging

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

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Columbia University Irving Medical Center
New York, New York, United States

Andrew J. Einstein, MD, PhD, Principal Investigator
Columbia Univeristy

GE Healthcare
NCT Number
MeSH Terms
COVID-19
Arrhythmias, Cardiac
Ventricular Dysfunction
Heart Diseases
Myocarditis
Ventricular Dysfunction, Left