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

Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04753762

Acronym

IMACovid

Enrollment

Registered

2021-02-15

Start date

2020-03-01

Completion date

2022-02-01

Last updated

2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Complication, COVID-19 Virus Disease

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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)
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

Countries

France

Outcome results