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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Viral Respiratory Infection; Covid19

Treatments: Diagnostic Test: 6-minute walk test; Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR); Diagnostic Test: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT04864899

UW21-005

Details and patient eligibility

About

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

Full description

This study aims to:

1. 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.
2. Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points.
3. 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.

Enrollment: 112 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

Recovered COVID-19 patients

Experimental group

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)

Diagnostic Test: 6-minute walk test

Recovered non-COVID-19 viral respiratory infections patients

Experimental group

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)

Diagnostic Test: 6-minute walk test

Age and gender matched controls

Experimental group

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)

Diagnostic Test: 6-minute walk test