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COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

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ClinicalTrials.gov Identifier: NCT04661657
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Andrew J. Einstein, MD, PhD, Columbia University

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.

Condition or disease Intervention/treatment
Covid19 Cardiac Disease Cardiac Arrhythmia Myocarditis Left Ventricular Dysfunction 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Percentage of myocardium demonstrating late gadolinium enhancement [ Time Frame: Up to 2 hours ]
    Percentage of myocardium demonstrating late gadolinium enhancement by cardiac magnetic resonance (CMR) imaging, determined using Circle cvi42 software.

  2. Extracellular Volume (ECV) Fraction [ Time Frame: Up to 2 hours ]
    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)).

  3. Left Ventricular Ejection Fraction [ Time Frame: Up to 2 hours ]
    Left ventricular ejection fraction (percent ejection fraction) by CMR imaging and determined using Circle cvi42 software.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661657


Contacts
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Contact: Frankie DeJesus, MS 2123057793 efd2116@cumc.columbia.edu
Contact: Kathleen Durkin, MS 2128531351 kd2649@columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Frankie DeJesus, MS    212-305-7793    efd2116@cumc.columbia.edu   
Contact: Kathleen Durkin, MS    2128531351    kd2649@columbia.edu   
Principal Investigator: Andrew J Einstein, MD,PhD         
Sub-Investigator: Marco R Tullio, MD         
Sponsors and Collaborators
Columbia University
GE Healthcare
Investigators
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Principal Investigator: Andrew J Einstein, MD, PhD Columbia Univeristy
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Responsible Party: Andrew J. Einstein, MD, PhD, Director, Nuclear Cardiology, Cardiac CT, and Cardiac MRI, Columbia University
ClinicalTrials.gov Identifier: NCT04661657    
Other Study ID Numbers: AAAT0787
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Ventricular Dysfunction
Heart Diseases
Ventricular Dysfunction, Left
Myocarditis
Cardiovascular Diseases
Pathologic Processes
Cardiomyopathies