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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Cardiac MRI
Diagnostic testPatients participate in an NIH funded cardiac MRI to assess their symptoms.
Echocardiogram
Diagnostic testPatients participate in an NIH funded cardiac echocardiogram to assess their symptoms.
6-minute walk test
Diagnostic testPatients participate in a 6-minute walk test to assess their symptoms.
Questionnaire
Diagnostic testPatients answer a survey-based questionnaire to assess their symptoms.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
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).
Sponsors and contacts
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Weill Medical College of Cornell University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator