COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

NCT04661657 | Completed

• 1 other identifier: AAAT0787
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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); Other: Cardiovascular Magnetic Resonance (CMR) Imaging

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); Other: Cardiovascular Magnetic Resonance (CMR) Imaging

Interventions

Transthoracic echocardiogram (TTE) OTHER

Subjects will undergo TTE imaging.

COVID-19; Control

Cardiovascular Magnetic Resonance (CMR) Imaging OTHER

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

COVID-19; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• GE Healthcare: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

COVID-19; Heart Diseases; Arrhythmias, Cardiac; Myocarditis; Ventricular Dysfunction, Left

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Andrew J. Einstein, MD, PhD

  Columbia Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 10, 2020
• Study Start: December 28, 2020
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

US (1)