Clinical trial NCT04661657: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry
Official title: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cardiac Disease
Cardiac Arrhythmia
Myocarditis
Left Ventricular Dysfunction
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2020-12-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage of myocardium demonstrating late gadolinium enhancement
timeFrame: Up to 2 hours
measure: Extracellular Volume (ECV) Fraction
timeFrame: Up to 2 hours
measure: Left Ventricular Ejection Fraction
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia Univeristy
name: Andrew J. Einstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: