Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors

NCT ID: NCT05164744

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2026-07-30

Brief Summary

The purpose of this study is to test if visualizing the heart with cardiac MRI/echo will be important in the understanding cardiac function and prediction of cardiopulmonary symptoms, physical effort tolerance, and outcomes in COVID-19 survivors. If successful, the research will allow us to identify the causes of lasting cardiopulmonary symptoms and begin developing cardiac and lung directed therapies accordingly.

Detailed Description

Coronavirus disease 2019 (COVID-19) is an ongoing global pandemic. Despite substantial short term mortality risk, the overwhelming majority of infected patients survive acute illness, resulting in a growing population at risk for long term events. Cardiopulmonary symptoms are common after COVID-19, as shown by survey data reporting fatigue (53%), dyspnea (43%), and worsened quality of life (44%) 60 days after acute infection, but mechanism and time course of symptoms are unknown. Recent studies and the investigator's preliminary data have shown myocardial tissue abnormalities on cardiac magnetic resonance (CMR) to be common in COVID-19 survivors - raising the possibility that symptoms stem from viral effects on the heart. However, CMR findings to date are limited by small size and clinical data susceptible to referral bias, raising uncertainty as to generalizability. It is also unknown whether altered myocardial tissue properties (fibrosis, edema) impact clinical outcomes.

The central hypothesis of the research is that CMR tissue characterization will be incremental to clinical assessment and cardiac contractile function for prediction of long-term cardiopulmonary symptoms, effort tolerance, and prognosis among COVID-19 survivors. To test this, the investigators will study patients from an active multiethnic New York City registry of COVID-19 survivors: the investigators have already leveraged echocardiographic imaging data from this registry to show that (1) adverse cardiac remodeling (dilation, dysfunction) markedly augments short term mortality, (2) COVID-19 acutely alters left and right ventricular remodeling, and (3) many patients who survive initial hospitalization for COVID-19 have adverse cardiac remodeling - including 40% with left ventricular (LV) dysfunction and 32% with adverse RV remodeling (dilation, dysfunction): the investigator's current proposal will extend logically on the preliminary data to test whether CMR tissue characterization provides incremental predictive utility with respect to reverse remodeling and prognosis. At least 510 COVID-19 survivors will be studied. Echo will be analyzed at time of and following COVID-19 for longitudinal remodeling, as will CMR at pre-specified (6-12, 36 month) follow-up timepoints. Established and novel CMR technologies will be employed, including assessment of cardiac and lung injury, high resolution (3D) myocardial tissue characterization, and cardiopulmonary blood oxygenation. In parallel, QOL, effort tolerance (6-minute walk test), biomarkers, and rigorous follow-up will be obtained to discern clinical implications and relative utility of imaging findings. Aim 1 will identify determinants of impaired quality of life and effort intolerance among COVID-19 survivors. Aim 2 will test whether myocardial tissue injury on CMR is associated with impaired contractility, and whether fibrosis predicts contractile recovery. Aim 3 will determine whether myocardial tissue injury is independently associated with adverse prognosis (new onset clinical heart failure, hospitalization, mortality). Results will address key knowledge gaps regarding COVID-19 effects on the heart necessary to guide surveillance, risk stratification, and targeted therapies for millions of COVID-19 survivors at risk for myocardial injury, cardiopulmonary symptoms, and adverse prognosis.

Conditions

COVID-19 Pneumonia; COVID-19; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Lower Respiratory Infection; COVID-19 Acute Bronchitis; Coronavirus Disease 2019

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diagnosed with COVID-19

Participants in the study cohort will have been diagnosed with COVID-19 by a PCR (polymerase chain reaction) positive test

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

Patients participate in an NIH funded cardiac MRI to assess their symptoms.

Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Patients participate in an NIH funded cardiac echocardiogram to assess their symptoms.

6-minute walk test

Intervention Type: DIAGNOSTIC_TEST

Patients participate in a 6-minute walk test to assess their symptoms.

Questionnaire

Intervention Type: DIAGNOSTIC_TEST

Patients answer a survey-based questionnaire to assess their symptoms.

Interventions

Cardiac MRI

Patients participate in an NIH funded cardiac MRI to assess their symptoms.

Intervention Type: DIAGNOSTIC_TEST

Echocardiogram

Patients participate in an NIH funded cardiac echocardiogram to assess their symptoms.

Intervention Type: DIAGNOSTIC_TEST

6-minute walk test

Patients participate in a 6-minute walk test to assess their symptoms.

Intervention Type: DIAGNOSTIC_TEST

Questionnaire

Patients answer a survey-based questionnaire to assess their symptoms.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Emergency room presentation and/or hospitalization with COVID-19 infection defined in accordance with established criteria as follows: SAR-CoV2 RT-PCR+ (severe acute respiratory syndrome coronavirus 2 reverse transcription polymerase chain reaction) and at least one of the following symptoms: dyspnea, cough, dysphagia, rhinorrhea, diarrhea, nausea/vomiting, myalgias, fever, syncope/presyncope.

Exclusion Criteria

• Contraindication to CMR (i.e. non-compatible pacemaker/defibrillator) or gadolinium (known hypersensitivity, eGFR (estimated globular filtration rate) <30 ml/min/1.73m2).
• Inability to provide informed consent (e.g. cognitive impairment).
• Unrelated condition (e.g. neoplasm) with life expectancy <12 months prohibiting follow-up.
• Patients with contraindications to gadolinium (known or suspected hypersensitivity, glomerular filtration rate < 30 ml/min/1.73m2) will undergo non-contrast MRI but will not be excluded from this study.
• Patients with known or suspected pregnancy based on Weill Cornell Radiology intake surveys (reviewed by a clinical RN (registered nurse), as well as research personnel) will be excluded from the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiwon Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian-Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status: RECRUITING

New York Presbyterian Queens

New York, New York, United States

Site Status: RECRUITING

Weill Cornell Medicine/New-York Presbyterian Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Manowitz, BS

Role: CONTACT

elm4036@med.cornell.edu

2127462627

Mahniz Reza, BA

Role: CONTACT

CovidHeartStudy@med.cornell.edu

2127462627

Facility Contacts

Marline Attallah, MD

Role: primary

CovidHeartStudy@med.cornell.edu

2127462627

Elizabeth Manowitz, BS

Role: backup

elm4036@med.cornell.edu

2127462627

Susan Ingenito

Role: primary

CovidHeartStudy@med.cornell.edu

7186702414

Elizabeth Manowitz, BS

Role: backup

elm4036@med.cornell.edu

2127462627

Elizabeth Manowitz, BS

Role: primary

elm4036@med.cornell.edu

2127462627

Mahniz Reza, BA

Role: backup

CovidHeartStudy@med.cornell.edu

2127462627

Other Identifiers

R01HL159055-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-02023362

Identifier Type: -

Identifier Source: org_study_id