Cardiac Magnetic Resonance Tissue Characterization in COVID-19 Survivors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Study Population will be comprised of 510 patients (Men and women ≥ 18 years old) with documented (SARS-CoV-2 RT-PCR+) COVID-19 infection, inclusive of patients with residual cardiopulmonary symptoms (shortness of breath, fatigue, chest pain) and asymptomatic patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac MRI

    Diagnostic test

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

  • Echocardiogram

    Diagnostic test

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

  • 6-minute walk test

    Diagnostic test

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

  • Questionnaire

    Diagnostic test

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

Treatment groups

510 Participants
are divided into 1 treatment group
Group A: Diagnosed with COVID-194 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Day of first study visit, > 3 months post acute COVID-19 infection
2

Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 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.

Time frame
12-36 months post first study visit
3

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

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).

Time frame
Day of first study visit, > 3 months post- acute COVID-19 infection
4

Blood oxygenation of participants at 12-36 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).

Time frame
12-36 months post first study visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator