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

NCT04864899 | Completed

• 1 other identifier: UW21-005
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; Viral Respiratory Infection

Outcome Measures

Primary Outcomes (6)

• 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.

  2 years

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

  2 years

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

  2 years

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

  2 years

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

  2 years

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

  2 years

Secondary Outcomes (4)

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

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (3)

Recovered COVID-19 patients

EXPERIMENTAL

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

Recovered non-COVID-19 viral respiratory infections patients

EXPERIMENTAL

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

Age and gender matched controls

EXPERIMENTAL

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

Interventions

Cardiac Magnetic Resonance Imaging (CMR) DIAGNOSTIC_TEST

Imaging

Age and gender matched controls; Recovered COVID-19 patients; Recovered non-COVID-19 viral respiratory infections patients

Blood test DIAGNOSTIC_TEST

Blood investigation

Age and gender matched controls; Recovered COVID-19 patients; Recovered non-COVID-19 viral respiratory infections patients

6-minute walk test DIAGNOSTIC_TEST

Correlating the cardiac MRI parameters with functional capacity

Age and gender matched controls; Recovered COVID-19 patients; Recovered non-COVID-19 viral respiratory infections patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hematologic Tests; Walk Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 29, 2021
• Study Start: September 1, 2021
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

HK (1)