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Cardiac Health After COVID-19 Study

This study is looking at how COVID-19 affects the heart long-term. Researchers will use cardiac MRI (a special heart scan) and echocardiograms (heart ultrasounds) to see if these tests can help understand heart function and predict ongoing symptoms like shortness of breath or fatigue in people who have recovered from COVID-19. You might be able to join if you were sick enough with COVID-19 to go to the emergency room or be hospitalized, and you are 18 or older. The goal is to find the causes of lasting heart and lung problems after COVID-19, which could help develop new treatments. The study is currently observational, meaning researchers are watching and collecting information without giving new treatments.

Study design
This is an observational study planning to enroll 510 participants. Researchers will be collecting information about participants' heart health after COVID-19.
What's involved
Participants will have a cardiac MRI, an echocardiogram, a 6-minute walk test, and answer a questionnaire. These tests assess your symptoms and heart health.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at least 3 months after their COVID-19 diagnosis, and then again 12-36 months after their first study visit.

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NCT05164744

Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors

Recruiting
Not specifiedAges 18+Observational
Weill Medical College of Cornell University
~510 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Cardiac MRIEchocardiogram6-minute walk testQuestionnaire

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) > 3 months post-COVID-19 (coronavirus disease 2019) diagnosis, at first study visit
Measured over Day of first study visit, > 3 months post acute COVID-19 infection
+15 more outcomes measured

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

Explore related trials

COVID-19 InfectionSAR-CoV2 RT-PCR

Where it's being run

3 sites across 1 states
New York3

Study leadership

  • Jiwon Kim, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Elizabeth Manowitz, BS
[email protected]
2127462627
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) > 3 months post-COVID-19 (coronavirus disease 2019) diagnosis, at first study visitDay of first study visit, > 3 months post acute COVID-19 infection

    Focal fibrosis scored on LGE(late gadolinium enhancement) CMR in affected LV segment based on transmural extent of hyperenhanced myocardium at \> 3 months post-COVID-19 diagnosis. Further categorized in accordance with established criteria (ischemic: subendocardial or transmural, non-ischemic: mid or epicardial). Total size (% LV myocardium) measured based on segmental scores, further quantified using the full-width half maximum method.

  • Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit12-36 months post first study visit

    Focal fibrosis scored on LGE-CMR in affected LV segment based on transmural extent of hyperenhanced myocardium at 12-36 months post first study visit. Further categorized in accordance with established criteria (ischemic: subendocardial or transmural, non-ischemic: mid or epicardial). Total size (% LV myocardium) measured based on segmental scores, further quantified using the full-width half maximum method.

  • Blood oxygenation of participants at > 3 months post-COVID-19 diagnosis, first study visitDay of first study visit, > 3 months post- acute COVID-19 infection

    Blood oxygenation in both the heart (LV/RV) and pulmonary arteries measured on QSM (quantitative susceptibility mapping) at \> 3 months post-COVID-19 diagnosis, first study visit: conversion from susceptibility to blood oxygenation. Compute left-right heart oxygen saturation difference (ΔSO2) for which venous saturation will be measured in the RV outflow tract/pulmonary artery (PA) junction (analogous to invasive cath), left and right pulmonary artery differential saturation and relative saturation (in relation to the RV), and mixed venous oxygen saturation (SvO2), which will be calculated by subtracting ΔSO2 (on QSM) from arterial oxygen saturation measured by pulse oximetry (obtained at conclusion of CMR exam).

  • Blood oxygenation of participants at 12-36 months post first study visit12-36 months post first study visit

    Blood oxygenation in both the heart (LV/RV) and pulmonary arteries measured on QSM (quantitative susceptibility mapping) at 12-36 months post first study visit: conversion from susceptibility to blood oxygenation. Compute left-right heart oxygen saturation difference (ΔSO2) for which venous saturation will be measured in the RV outflow tract/pulmonary artery (PA) junction (analogous to invasive cath), left and right pulmonary artery differential saturation and relative saturation (in relation to the RV), and mixed venous oxygen saturation (SvO2), which will be calculated by subtracting ΔSO2 (on QSM) from arterial oxygen saturation measured by pulse oximetry (obtained at conclusion of CMR exam).

  • Lung abnormalities in participants at > 3 months post-COVID-19 infectionDay of first study visit, > 3 months post- acute COVID-19 infection

    Lung abnormalities at \> 3 months post-COVID-19 infection graded on high resolution 3D MRA (magnetic resonance angiography) as (1) consolidative or ground glass signal abnormality or (2) linear areas of scarring and fibrosis. A validated semi-quantitative scoring system is then be applied as follows: each of the 5 lung lobes scored based on extent of anatomic involvement where 0=no involvement: 1=\<5% involvement; 2=5-25% involvement; 3=26-59% involvement; 4=51-75% involvement; and 5=\>75% involvement. The resulting global score is the sum of each individual lobar score (range 0-25).

  • Lung abnormalities in participants at 12-36 months post first study visit12-36 months post first study visit

    Lung abnormalities at 12-36 months post first study visit graded on high resolution 3D MRA (magnetic resonance angiography) as (1) consolidative or ground glass signal abnormality or (2) linear areas of scarring and fibrosis. A validated semi-quantitative scoring system is then be applied as follows: each of the 5 lung lobes scored based on extent of anatomic involvement where 0=no involvement: 1=\<5% involvement; 2=5-25% involvement; 3=26-59% involvement; 4=51-75% involvement; and 5=\>75% involvement. The resulting global score is the sum of each individual lobar score (range 0-25).

  • Quality of life (QOL) in participants at > 3 months post-COVID-19 diagnosis, at first study visit based on clinical indices and symptoms assessed by the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire.Day of first study visit, > 3 months post- acute COVID-19 infection

    QOL at \> 3 months post-COVID-19 diagnosis evaluated based on scores from the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire (0-10 scale per 7 categories) which is represented by a standardized T-score (mean=50, Standard Deviation=10). QOL data will be analyzed as a continuous variable.

  • Quality of life (QOL) in participants at 12-36 months post first study visit based on clinical indices and symptoms assessed by the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire.12-36 months post first study visit

    QOL at 12-36 months post first study visit evaluated based on scores from the (Patient-Reported Outcomes Measurement Information System) PROMIS-29 questionnaire (0-10 scale per 7 categories) which is represented by a standardized T-score (mean=50, Standard Deviation=10). QOL data will be analyzed as a continuous variable.

  • Effort tolerance as measured by a 6-minute walk test at > 3 months post-COVID-19 diagnosis, at first study visitDay of first study visit, > 3 months post- acute COVID-19 infection

    Effort tolerance \> 3 months post-COVID-19 diagnosis quantified via 6-minute walk test, measured as a continuous variable based on total duration walked (during 6-minute test time, or time of patient requested test termination), as well as a age and gender based binary cutoffs employed in prior literature. Impaired effort tolerance will be tested both as a binary (\<85% predicted) and continuous variable (distance) for statistical analysis.

  • Effort tolerance as measured by a 6-minute walk test at 12-36 months post first study visit12-36 months post first study visit

    Effort tolerance at 12-36 months post first study visit quantified via 6-minute walk test, measured as a continuous variable based on total duration walked (during 6-minute test time, or time of patient requested test termination), as well as a age and gender based binary cutoffs employed in prior literature. Impaired effort tolerance will be tested both as a binary (\<85% predicted) and continuous variable (distance) for statistical analysis.

  • Participants with edema based on cardiac imaging (MRI and echocardiogram) at > 3 months post-COVID-19 diagnosis, at first study visitDay of first study visit, > 3 months post- acute COVID-19 infection

    Edema at \> 3 months post-COVID-19 diagnosis: Identified on T2 mapping assessed on a segmental basis corresponding to LGE-CMR. Elevated T2 (i.e. edema) will defined in accordance with established criteria. Myocardial T2 relaxation times extracted from T2 maps after contouring of endocardial and epicardial borders, T2 maps will be analyzed using a 16 segment AHA (American Heart Association) model. T2 values above an established threshold will be indicate presence or absence of edema where T2 value of \>80 ms will be used to distinguish edema from healthy myocardium. Global edema assessed as sum of number of affected LV segments. Exploratory analyses test additional indices of edema severity, as assessed based on maximal and mean T2 in all LV segments.

  • Participants with edema based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit12-36 months post first study visit

    Edema at 12-36 months post first study visit : Identified on T2 mapping assessed on a segmental basis corresponding to LGE-CMR. Elevated T2 (i.e. edema) will defined in accordance with established criteria. Myocardial T2 relaxation times extracted from T2 maps after contouring of endocardial and epicardial borders, T2 maps will be analyzed using a 16 segment AHA (American Heart Association) model. T2 values above an established threshold will be indicate presence or absence of edema where T2 value of \>80 ms will be used to distinguish edema from healthy myocardium. Global edema assessed as sum of number of affected LV segments. Exploratory analyses test additional indices of edema severity, as assessed based on maximal and mean T2 in all LV segments.

  • Participants with diffuse fibrosis based on cardiac imaging (MRI and echocardiogram) at > 3 months post-COVID-19 diagnosis, at first study visitDay of first study visit, > 3 months post- acute COVID-19 infection

    Diffuse fibrosis at 6-12 months post-COVID-19 diagnosis assessed based on extracellular volume (ECV) measured by T1 values in co-registered regions on pre- and post-contrast Modified Look-Locker Inversion (MOLLI): ECV will be calculated via an established formula ECV = (1-hematocrit) \* \[(1/T1myo post - 1/T1myo pre) / (1/T1blood post - 1/T1bloodpre)\].

  • Participants with diffuse fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit12-36 months post first study visit

    Diffuse fibrosis at 12-36 months post first study visit assessed based on extracellular volume (ECV) measured by T1 values in co-registered regions on pre- and post-contrast Modified Look-Locker Inversion (MOLLI): ECV will be calculated via an established formula ECV = (1-hematocrit) \* \[(1/T1myo post - 1/T1myo pre) / (1/T1blood post - 1/T1bloodpre)\].

  • Quality of life (QOL) in participants at > 3 months post-COVID-19 diagnosis, at first study visit based on clinical indices and symptoms assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)Day of first study visit, > 3 months post- acute COVID-19 infection

    The Minnesota Living with Heart Failure (MLHFQ) scores at \> 3 months post-COVID-19 diagnosis range from 0-105 where a higher score indicates more significant impairment in health related quality of life. QOL data will be analyzed as a continuous variable.

  • Quality of life (QOL) in participants based on clinical indices and symptoms assessed by the Seattle Angina (SAQ) questionnaire at 12-36 months post first study visit12-36 months post first study visit

    Seattle Angina (SAQ) questionnaires scored at 12-36 months post first study visit between 0-100 where higher scores indicate better functional status. QOL data will be analyzed as a continuous variable.