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

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ClinicalTrials.gov Identifier: NCT04753762
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Laura FILIPPETTI, Central Hospital, Nancy, France

Tracking Information
First Submitted Date January 26, 2021
First Posted Date February 15, 2021
Last Update Posted Date February 15, 2021
Actual Study Start Date March 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2021)
  • To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 11, 2021)
  • To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12+/-2 months ]
    Follow-up at 12+/-2 months from COVID-19 infection : - status (dead or alive)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection
Official Title Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients increase troponin level > 50ng/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
Condition
  • COVID-19 Virus Disease
  • Cardiac Complication
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 11, 2021)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laura FILIPPETTI, MD +33383153240 l.filippetti@chru-nancy.fr
Contact: Aboubaker CHERIFI, Ms a.cherifi@chru-nancy.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04753762
Other Study ID Numbers 2020PI086
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Laura FILIPPETTI, Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators
Principal Investigator: Laura FILIPPETTI, MD CHRU NANCY
PRS Account Central Hospital, Nancy, France
Verification Date February 2021