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

NCT05184114 | Completed

• 1 other identifier: UW 21-005
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19; Myocarditis

Keywords

COVID-19; Coronavirus; SARS-CoV-2; CMR; cardiac magnetic resonance imaging; Recovered COVID-19; Myocarditis

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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

  2 years

Secondary Outcomes (6)

• Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as death.

  2 years

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

  2 years

• Number of Participants with cardiac arrest.

  2 years

• Number of Participants with ventricular tachycardia.

  2 years

• Number of Participants with ventricular fibrillation.

  2 years

Study Arms (4)

Recovered COVID-19 patients

ACTIVE COMPARATOR

Recovered 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.

Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests

non-COVID-19 patients with viral respiratory infections

EXPERIMENTAL

non-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.

Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests

Volunteers as age and gender matched controls.

EXPERIMENTAL

Volunteer controls will undergo one CMR examination. At time of CMR examinations, patients will have blood tests.

Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests

Volunteers who planning to receive a 2-dose COVID-19 vaccine as vaccination controls

EXPERIMENTAL

Vaccination 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.

Diagnostic Test: Cardiac Magnetic Resonance, Blood Tests

Interventions

Cardiac Magnetic Resonance, Blood Tests DIAGNOSTIC_TEST

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

Recovered COVID-19 patients; Volunteers as age and gender matched controls.; Volunteers who planning to receive a 2-dose COVID-19 vaccine as vaccination controls; non-COVID-19 patients with viral respiratory infections

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.
• 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.

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

Related Publications (1)

• 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.

  PMID: 38057820 DERIVED

MeSH Terms

Conditions

COVID-19; Myocarditis; Coronavirus Infections

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

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: January 5, 2022
• First Posted: January 11, 2022
• Study Start: October 4, 2021
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)