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

Covid19 Clinical Trial

— R-COVID-CMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864899
• Other study ID #: UW21-005
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: The University of Hong Kong
• Contact: Ming-Yen NG, BMBS
• Phone: 22554524
• Email: myng2[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: October 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiratory Tract Infections
• Viral Respiratory Infection

Intervention

Diagnostic Test:
• Cardiac Magnetic Resonance Imaging (CMR)
Imaging
• Blood test
Blood investigation
• 6-minute walk test
Correlating the cardiac MRI parameters with functional capacity

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The correlation of these myocardial characteristics to biventricular structure at all time-points.		2 years
Primary	The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.		2 years
Primary	The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.		2 years
Primary	The correlation of these myocardial characteristics to clinical symptoms at all time-points.		2 years
Primary	The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.		2 years
Secondary	Follow-up patients beyond the end of this study to assess for hard outcomes such as death.		2 years
Secondary	Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.		2 years
Secondary	Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.		2 years
Secondary	Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.		2 years