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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04753762
Collaborator
(none)
50
Enrollment
1
Location
32
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection
    Actual Study Start Date :
    Mar 1, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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

    2. 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).

    3. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laura FILIPPETTI Vandœuvre-lès-Nancy France 54500

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Laura FILIPPETTI, MD, CHRU NANCY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laura FILIPPETTI, Doctor, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT04753762
    Other Study ID Numbers:
    • 2020PI086
    First Posted:
    Feb 15, 2021
    Last Update Posted:
    Feb 15, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Virus Diseases

    Study Results

    No Results Posted as of Feb 15, 2021