Clinical trial NCT04864899: Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Official title: Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Viral Respiratory Infection
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 2 years
measure: The correlation of these myocardial characteristics to biventricular structure at all time-points.
timeFrame: 2 years
measure: The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
timeFrame: 2 years
measure: The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
timeFrame: 2 years
measure: The correlation of these myocardial characteristics to clinical symptoms at all time-points.
timeFrame: 2 years
measure: The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.
timeFrame: 2 years
Secondary outcomes:
measure: Follow-up patients beyond the end of this study to assess for hard outcomes such as death.
timeFrame: 2 years
measure: Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.
timeFrame: 2 years
measure: Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.
timeFrame: 2 years
measure: Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: