Covid19R-COVID-CMRNCT04864899
Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
A study testing Cardiac Magnetic Resonance Imaging (CMR), Blood test and 6-minute walk test in people with Covid19 and Viral Respiratory Infection, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, Viral Respiratory Infection
- What is being tested?
- Cardiac Magnetic Resonance Imaging (CMR), Blood test and 6-minute walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
This is a prospective cohort study that aims to clinical significance of subclinical myocardial involvement in recovered COVID-19 patients using cardiovascular magnetic resonance.
Read the detailed description
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.
- Conditions
- Covid19, Viral Respiratory Infection
- Being tested
- Cardiac Magnetic Resonance Imaging (CMR), Blood test, 6-minute walk test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (CMR)Diagnostic test
Imaging
Blood testDiagnostic test
Blood investigation
6-minute walk testDiagnostic test
Correlating the cardiac MRI parameters with functional capacity
| Study group | Role | What they receive |
|---|---|---|
| Recovered COVID-19 patients | Experimental | Not described Receives: 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 | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR); Diagnostic Test: Blood test; Diagnostic Test: 6-minute walk test |
| Age and gender matched controls | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR); Diagnostic Test: Blood test; Diagnostic Test: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
The correlation of these myocardial characteristics to biventricular structure at all time-points.
Measured: 2 years
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
Measured: 2 years
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
Measured: 2 years
The correlation of these myocardial characteristics to clinical symptoms at all time-points.
Measured: 2 years
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.
Measured: 2 years
Secondary outcomes (4)
Follow-up patients beyond the end of this study to assess for hard outcomes such as death.
Measured: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.
Measured: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.
Measured: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Sep 2021
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ng Ming-Yen, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864899
- Sponsor's protocol ID
- UW21-005
- Acronym
- R-COVID-CMR
- Status last verified
- May 2025
- First submitted
- 19 Mar 2021
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
- ClinicalTrials.gov ID
- NCT04864899
- Acronym / sponsor ID
- R-COVID-CMR / UW21-005
- Conditions
- Covid19, Viral Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Recovered COVID-19 patients
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance Imaging (CMR)Imaging | Diagnostic test | Age and gender matched controls, Recovered COVID-19 patients, Recovered non-COVID-19 viral respiratory infections patients |
| Blood testBlood investigation | Diagnostic test | Age and gender matched controls, Recovered COVID-19 patients, Recovered non-COVID-19 viral respiratory infections patients |
| 6-minute walk testCorrelating the cardiac MRI parameters with functional capacity | Diagnostic test | Age and gender matched controls, Recovered COVID-19 patients, Recovered non-COVID-19 viral respiratory infections patients |
Primary outcome
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
The correlation of these myocardial characteristics to biventricular structure at all time-points.
Time frame: 2 years
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
Time frame: 2 years
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
Time frame: 2 years
The correlation of these myocardial characteristics to clinical symptoms at all time-points.
Time frame: 2 years
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.
Time frame: 2 years
4 secondary outcomes
Follow-up patients beyond the end of this study to assess for hard outcomes such as death.
Time frame: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.
Time frame: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.
Time frame: 2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging (CMR), Blood test and 6-minute walk test in people with Covid19 and Viral Respiratory Infection, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.