Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05164744

Conditions

COVID-19 Pneumonia

COVID-19

COVID-19 Respiratory Infection

COVID-19 Acute Respiratory Distress Syndrome

COVID-19 Lower Respiratory Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cardiac MRI

Echocardiogram

6-minute walk test

Questionnaire

Study Details

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.

Conditions

COVID-19 Pneumonia

COVID-19

COVID-19 Respiratory Infection

COVID-19 Acute Respiratory Distress Syndrome

COVID-19 Lower Respiratory Infection

Study ID

NCT05164744

Start date

Jul 1, 2021

Status verified date

Jan, 2026

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

510 participants

Anticipated

Interventions and Outcome Measures

Arms

Diagnosed with COVID-19

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

Interventions

Cardiac MRI

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

Echocardiogram

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

6-minute walk test

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

Questionnaire

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

Primary outcome measure

  • Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) > 3 months post-COVID-19 (coronavirus disease 2019) diagnosis, at first study visit [ Time Frame: Day of first study visit, > 3 months post acute COVID-19 infection ]
  • Participants with focal fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • Blood oxygenation of participants at > 3 months post-COVID-19 diagnosis, first study visit [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • Blood oxygenation of participants at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • Lung abnormalities in participants at > 3 months post-COVID-19 infection [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • Lung abnormalities in participants at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • 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. [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • 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. [ Time Frame: 12-36 months post first study visit ]
  • Effort tolerance as measured by a 6-minute walk test at > 3 months post-COVID-19 diagnosis, at first study visit [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • Effort tolerance as measured by a 6-minute walk test at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • Participants with edema based on cardiac imaging (MRI and echocardiogram) at > 3 months post-COVID-19 diagnosis, at first study visit [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • Participants with edema based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • Participants with diffuse fibrosis based on cardiac imaging (MRI and echocardiogram) at > 3 months post-COVID-19 diagnosis, at first study visit [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • Participants with diffuse fibrosis based on cardiac imaging (MRI and echocardiogram) at 12-36 months post first study visit [ Time Frame: 12-36 months post first study visit ]
  • 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) [ Time Frame: Day of first study visit, > 3 months post- acute COVID-19 infection ]
  • 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 visit [ Time Frame: 12-36 months post first study visit ]

Central Contacts and Locations

Central contacts

Elizabeth Manowitz, BS

2127462627elm4036@med.cornell.edu

Mahniz Reza, BA

2127462627CovidHeartStudy@med.cornell.edu

Locations

New York Presbyterian-Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215-3609

Contacts

Marline Attallah, MD

2127462627CovidHeartStudy@med.cornell.edu

Elizabeth Manowitz, BS

2127462627elm4036@med.cornell.edu

Principal Investigator:

Jiwon Kim, MD

New York Presbyterian Queens

Recruiting

New York, New York, United States, 10021

Contacts

Susan Ingenito

7186702414CovidHeartStudy@med.cornell.edu

Elizabeth Manowitz, BS

2127462627elm4036@med.cornell.edu

Principal Investigator:

Jiwon Kim, MD

Weill Cornell Medicine/New-York Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Elizabeth Manowitz, BS

2127462627elm4036@med.cornell.edu

Mahniz Reza, BA

2127462627CovidHeartStudy@med.cornell.edu

Principal Investigator:

Jiwon Kim, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • coronavirus disease 2019,

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-01-22.