COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Myocarditis; Cardiac Arrhythmia; Cardiac Disease; Left Ventricular Dysfunction
• Intervention / Treatment: Other: Transthoracic echocardiogram (TTE); Other: Cardiovascular Magnetic Resonance (CMR) Imaging

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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).
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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of myocardium demonstrating late gadolinium enhancement	Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.	Up to 2 hours
Extracellular Volume (ECV) Fraction	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)).	Up to 2 hours
Left Ventricular Ejection Fraction	Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.	Up to 2 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Andrew J. Einstein, MD, PhD, Columbia Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): January 22, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Cardiomyopathies; Heart Diseases; COVID-19; Arrhythmias, Cardiac; Myocarditis; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: AAAT0787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No