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

NCT ID: NCT04864899

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-08-06

Brief Summary

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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

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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.

Conditions

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Covid19 Viral Respiratory Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Recovered COVID-19 patients

Group Type EXPERIMENTAL

Cardiac Magnetic Resonance Imaging (CMR)

Intervention Type DIAGNOSTIC_TEST

Imaging

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood investigation

6-minute walk test

Intervention Type DIAGNOSTIC_TEST

Correlating the cardiac MRI parameters with functional capacity

Recovered non-COVID-19 viral respiratory infections patients

Group Type EXPERIMENTAL

Cardiac Magnetic Resonance Imaging (CMR)

Intervention Type DIAGNOSTIC_TEST

Imaging

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood investigation

6-minute walk test

Intervention Type DIAGNOSTIC_TEST

Correlating the cardiac MRI parameters with functional capacity

Age and gender matched controls

Group Type EXPERIMENTAL

Cardiac Magnetic Resonance Imaging (CMR)

Intervention Type DIAGNOSTIC_TEST

Imaging

Blood test

Intervention Type DIAGNOSTIC_TEST

Blood investigation

6-minute walk test

Intervention Type DIAGNOSTIC_TEST

Correlating the cardiac MRI parameters with functional capacity

Interventions

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Cardiac Magnetic Resonance Imaging (CMR)

Imaging

Intervention Type DIAGNOSTIC_TEST

Blood test

Blood investigation

Intervention Type DIAGNOSTIC_TEST

6-minute walk test

Correlating the cardiac MRI parameters with functional capacity

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ng Ming-Yen

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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UW21-005

Identifier Type: -

Identifier Source: org_study_id

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