Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection

Completed

• Conditions: COVID-19 Virus Disease; Cardiac Complication

• Registration Number: NCT04753762
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...

Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis.

Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Study Completion: 2022-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Cardiac involvement confirmed : increase troponin level > 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
• Absence of severe renal failure (CKD EPI > 30ml/min/1.73m²)
• Cardic imaging (MRI and TTE) performed during 4 months from COVID-19 infection

Exclusion Criteria

• Cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...)
• Vulnerable patient (pregnancy, adult under legal protection)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection	1 to 4 months after COVID 19 infection	Cardiac MRI is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.
To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection	1 to 4 months after COVID 19 infection	Cardiac TTE imaging is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.

Secondary Outcome Measures

Name	Time	Method
To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection	12 +/- 2 months	Cardiac imaging are performed 12 +/-2 months after COVID-19 infection
To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection	12+/-2 months	Follow-up at 12+/-2 months from COVID-19 infection : - medical consultation to collect cardiac events (heart failure, arrythmias, chest pain).
To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection	12+/-2 months	Follow-up at 12+/-2 months from COVID-19 infection : - status (dead or alive)

Trial Locations

Locations (1)

Laura FILIPPETTI; 🇫🇷 Vandœuvre-lès-Nancy, France