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

Not Applicable

Recruiting

• Conditions: Covid19; Viral Respiratory Infection
• Interventions: Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR); Diagnostic Test: Blood test; Diagnostic Test: 6-minute walk test

• Registration Number: NCT04864899
• Lead Sponsor: The University of Hong Kong

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Study Start: 2021-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovered COVID-19 patients	Blood test	-
Age and gender matched controls	Cardiac Magnetic Resonance Imaging (CMR)	-
Recovered non-COVID-19 viral respiratory infections patients	6-minute walk test	-
Age and gender matched controls	6-minute walk test	-
Recovered COVID-19 patients	Cardiac Magnetic Resonance Imaging (CMR)	-
Recovered non-COVID-19 viral respiratory infections patients	Blood test	-
Recovered COVID-19 patients	6-minute walk test	-
Recovered non-COVID-19 viral respiratory infections patients	Cardiac Magnetic Resonance Imaging (CMR)	-
Age and gender matched controls	Blood test	-

Primary Outcome Measures

Name	Time	Method
The correlation of these myocardial characteristics to clinical symptoms at all time-points.	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 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 functional capacity (6 minute walk test) at all time-points.	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong