COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661657
• Other study ID #: AAAT0787
• Status: Completed
• Start date: December 28, 2020
• Est. completion date: January 22, 2022

Study information

• Verified date: June 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 22, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiac Disease
• COVID-19
• Covid19
• Heart Diseases
• Left Ventricular Dysfunction
• Myocarditis
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Transthoracic echocardiogram (TTE)
Subjects will undergo TTE imaging.
• Cardiovascular Magnetic Resonance (CMR) Imaging
Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Extracellular Volume (ECV) Fraction	Extracellular volume fraction measured by CMR imaging. ECV determined using Circle cvi42 software and using formula ECV = (1-hematocrit) × (?(1/T1myocardium)/?(1/T1blood)).	Up to 2 hours
Primary	Left Ventricular Ejection Fraction	Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.	Up to 2 hours