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NCT Number: NCT04864899

Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)

This is a prospective cohort study that aims to clinical significance of subclinical myocardial involvement in recovered COVID-19 patients using cardiovascular magnetic resonance.

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Key information

About this study

This study aims to:

  • Determine the extent of myocardial involvement of COVID-19, as assessed by Cardiovascular Magnetic Resonance (CMR), 2 weeks after patient recovery, at 3-month post discharge and at 1-year post discharge.
  • Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points.
  • Follow up recovered COVID-19 patients beyond the end of this study to assess for hard outcomes such as death, heart failure hospitalization, cardiac arrest and ventricular tachycardia/ fibrillation.

Recovered COVID-19 patients and age and gender matched controls subjects will be recruited.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recovered COVID-19 patients

Definition of recovered COVID-19 patient:

  • COVID-19 diagnosis = established by a positive reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome coronavirus-2 [SARS-CoV2] and recovered from COVID-19.
  • Recovery = based on two criteria: (1) two negative nasopharyngeal swab RT-PCR results >24 hours apart and (2) absence of fever and improvement in respiratory symptoms.
  • Recovered non-COVID-19 patients with viral respiratory infections confirmed with viral polymerase chain reaction testing AND with a confirmed negative COVID-19 RT-PCR test.
  • Age and gender matched controls with no cardiac risk factors, not on cardiac medications, no history of myocardial infarction, heart failure or myocarditis, negative COVID-19 RT-PCR test and negative COVID-19 antibodies test.

Exclusion criteria

  • Previous myocardial infarction or myocarditis unrelated to COVID-19 infection
  • History of heart failure unrelated to COVID-19 infection
  • Presence of pacemakers or implantable cardiac defibrillators
  • Any contraindication for CMR testing
  • Renal impairment with eGFR <45ml/min/1.73m2
  • Limited life expectancy <1 year, for example due to pulmonary disease, cancer or significant hepatic failure
  • Refusal or inability to sign an informed consent.
  • Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits

Treatment and study plan

Cardiac Magnetic Resonance Imaging (CMR)

Diagnostic Test

Imaging

Blood test

Diagnostic Test

Blood investigation

6-minute walk test

Diagnostic Test

Correlating the cardiac MRI parameters with functional capacity

Primary outcomes

  1. The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), change from 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.

    Time frame: 2 years

  2. The correlation of these myocardial characteristics to biventricular structure at all time-points.

    Time frame: 2 years

  3. The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.

    Time frame: 2 years

  4. The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.

    Time frame: 2 years

  5. The correlation of these myocardial characteristics to clinical symptoms at all time-points.

    Time frame: 2 years

  6. The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.

    Time frame: 2 years

Secondary outcomes

  1. Follow-up patients beyond the end of this study to assess for hard outcomes such as death.

    Time frame: 2 years

  2. Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.

    Time frame: 2 years

  3. Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.

    Time frame: 2 years

  4. Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: R-COVID-CMR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2021
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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