AzTrials
AzTrials

COVID-19R-COVID-CMRNCT05184114

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

A study testing Cardiac Magnetic Resonance, Blood Tests in people with COVID-19 and Myocarditis, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: Coronavirus disease 2019 (COVID-19) remains a major health issue resulting in >800,000 deaths as of 30th August 2020. A concerning discovery of COVID-19 is the involvement of the myocardium. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19, Myocarditis
What is being tested?
Cardiac Magnetic Resonance, Blood Tests
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteHong Kong
Study dates
4 Oct 2021to 8 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.
  • Vaccination controls who planning to receive a 2-dose COVID-19 vaccine, with no history of myocardial infarction, heart failure or myocarditis AND with a confirmed negative COVID-19 RT-PCR 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.

Hong Kong1 site
  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Introduction:

Coronavirus disease 2019 (COVID-19) remains a major health issue resulting in >800,000 deaths as of 30th August 2020. A concerning discovery of COVID-19 is the involvement of the myocardium. Several case studies including one from our group (recent study publication in JACC Cardiovascular Imaging led by the principal investigator of this grant application) have demonstrated subclinical myocardial inflammation in patients using cardiac magnetic resonance imaging (CMR) who have recovered from COVID-19. Furthermore at a cellular level, a recent autopsy study indicated that the severe acute respiratory syndrome coronavirus-2 is present in the myocardial tissue. The study further described invasion and viral progeny occurring in the myocardial interstitial cells and as such is a concerning development with the longer-term implications being unknown. These concerns have been noticed by the cardiology and non-cardiology medical community, with some expressing concerns of a new cause for cardiomyopathy and heart failure secondary to COVID-195. Therefore, it is critical that further studies are conducted to determine the longer-term outcome for patients.

Read the detailed description

COVID-19 Cardiovascular Complications:

So far, COVID-19 has been linked to myocarditis, myocardial infarction, thrombosis/ hypercoaguable state and reduced cardiac function. At an early stage of the COVID-19 pandemic, it became apparent that cardiac complications were quite prevalent in COVID-19 patients, with a study from Wuhan showing 28% of patients having raised troponin levels and that raised troponin levels were correlated with poor outcome including death. In three case series using CMR to evaluate patients, the prevalence of myocardial infarcts ranged from 0% to 12%, myocardial inflammation was present in 56% to 60% of patients and reduced LV function was present in up to 7% of patients.

Role of CMR Imaging in COVID-19:

CMR is unique amongst the cardiac imaging modalities in providing a comprehensive evaluation of the heart structure, function and tissue characterisation. The European Society of Cardiology recognises CMR as the gold standard for assessing cardiac systolic function and volumes due to the high reproducibility between observers. Thus it allows for differences in cardiac systolic function and volumes to be detected earlier and with smaller sample sizes compared to echocardiography. CMR's tissue characterisation capabilities are unavailable to other modalities, and does not require ionising radiation or radioactive tracers (unlike computed tomography or nuclear imaging), which is ideal for follow-up testing. It has multiple techniques to identify myocardial inflammation / oedema (eg. T2/T1 mapping), focal fibrosis (eg. late gadolinium enhancement [LGE] quantification), and diffuse fibrosis (extracellular volume or ECV quantification). The newest pixel-wise quantitative T1/T2-mapping techniques are also named by the ESC as one of six most innovative technologies to evaluate patients with heart failure.

Thus, in the context of COVID-19, CMR is well positioned to assess for myocarditis and its long-term consequences, such as the development of myocardial fibrosis, cardiac remodeling and ultimately dysfunction and failure. This is attested to by the American College of Cardiology and European Society of Cardiology.

Knowledge Gap - Long-Term Impact of COVID-19 related Myocardial Inflammation:

Several studies have shown that for acute myocarditis, a majority of patients show a reduction in oedema and fibrosis, and improvement in left ventricular (LV) ejection fraction (LVEF). However, a proportion of patients show ongoing chronic myocarditis and deterioration on ventricular function, even progressing to dilated cardiomyopathy, clinical heart failure and death. The long-term impact of myocardial inflammation in COVID-19 patients is unknown. COVID-19 may follow a similar cardiac trajectory as other viral illnesses that affect the heart, and given the early reports of cardiac involvement post COVID-19, it is reasonable to expect that a proportion of COVID-19 survivors will develop adverse long-term consequences of cardiac morbidity and mortality. It is thus important to elucidate the determinants of clinical non-resolution of COVID-19 myocarditis, and to identify these signs early, before permanent damage occurs to cardiac structure and function. Furthermore, it is important to compare COVID-19 to patients with non-COVID-19 patients with viral respiratory infections to allow us to better understand the cardiovascular risks posed by COVID-19 compared to other viral respiratory illnesses.

Preliminary Data:

In addition to the aforementioned studies demonstrating myocardial involvement in COVID-19 survivors, our group has not only published similar findings in a CMR study, but concernedly, our patients had less severe (mild to moderate) initial COVID-19 and a majority were asymptomatic at follow-up, whilst the other studies were in patients with greater COVID-19 severity and had residual cardiac symptoms. Yet, the investigators still demonstrated that 56% of our cohort had imaging evidence of subclinical myocardial inflammation, a significant proportion of which also had serological markers (eg. troponin, c-reactive protein and white cell count) to support ongoing inflammation even at 2 months post hospital discharge. These findings are concerning in that many COVID-19 survivors have unrecognised myocardial inflammation that may be untreated, a proportion of which may resolve spontaneously, but some may go on to develop dilated cardiomyopathy and/or heart failure.

Being tested
Cardiac Magnetic Resonance, Blood Tests
Keywords
COVID-19, Coronavirus, SARS-CoV-2, CMR, cardiac magnetic resonance imaging, Recovered COVID-19, Myocarditis
Medical subject headings
COVID-19, Myocarditis, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Magnetic Resonance, Blood TestsDiagnostic test

    Imaging, blood investigations (white cell count, C-reactive protein, NT-proBNP, lactate dehydrogenase and high sensitivity troponin)

Study groups in NCT05184114
Study groupRoleWhat they receive
Recovered COVID-19 patientsActive comparatorRecovered COVID-19 Patients will undergo three CMR examinations. The scans will take place at (i) within 2 weeks of confirmed recovery, (ii) 3 months after recovery and (iii) 1 year after recovery. At time of CMR examinations, patients will have blood tests.
Receives: Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests
non-COVID-19 patients with viral respiratory infectionsExperimentalnon-COVID-19 Patients will undergo three CMR examinations. The scans will take place at (i) within 2 weeks of confirmed recovery, (ii) 3 months after recovery and (iii) 1 year after recovery. At time of CMR examinations, patients will have blood tests.
Receives: Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests
Volunteers as age and gender matched controls.ExperimentalVolunteer controls will undergo one CMR examination. At time of CMR examinations, patients will have blood tests.
Receives: Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests
Volunteers who planning to receive a 2-dose COVID-19 vaccine as vaccination controlsExperimentalVaccination controls will undergo two CMR examinations. The scans will take place (i) within 2 weeks before received 1st dose of COVID-19 vaccine and (ii) within 2 weeks (preferably 5-7 days) after receiving the 2nd dose of COVID-19 vaccine. At time of CMR examinations, patients will have blood tests.
Receives: Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.

    Measured: 1 year

  2. The correlation of these myocardial characteristics to biventricular structure, function (CMR cine/strain), blood biomarkers of inflammation, clinical symptoms, and functional capacity (6 minute walk test) at all time-points

    Measured: 2 years

Secondary outcomes (6)
  1. Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as death.

    Measured: 2 years

  2. Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.

    Measured: 2 years

  3. Number of Participants with cardiac arrest.

    Measured: 2 years

  4. Number of Participants with ventricular tachycardia.

    Measured: 2 years

  5. Number of Participants with ventricular fibrillation.

    Measured: 2 years

  6. Rate of subclinical myocardial inflammation post COVID-19 vaccination.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start4 Oct 2021
  3. Primary completion8 Aug 2024
  4. Study completion8 Aug 2024

Resources

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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05184114
Sponsor's protocol ID
UW 21-005
Acronym
R-COVID-CMR
Status last verified
May 2025
First submitted
5 Jan 2022
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ng MY, Tam CH, Lee YP, Fong HTA, Wong CK, Ng WKC, Yeung MHY, Ling WI, Tsao S, Wan EYF, Ferreira V, Yan AT, Siu CW, Yiu KH, Hung IF. Post-COVID-19 vaccination myocarditis: a prospective cohort study pre and post vaccination using cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2023 Dec 7;25(1):74. doi: 10.1186/s12968-023-00985-2.

    PubMed 38057820

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Magnetic Resonance, Blood Tests in people with COVID-19 and Myocarditis, 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 7 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), 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184114, which also lists 1 linked publication.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in