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NCT04358952 Clinical Trial

Myocardial Involvement of Severe Acute Respiratory Syndrome-Cov-2 (Covid19) Infected Patients

Cardiomyopathies Clinical Trial

— COCARDE  

Official title:
Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04358952
Other study ID # RC31/20/0117
Secondary ID 2020-A00852-37
Status Completed
Phase
First received
Last updated
Start date April 4, 2020
Est. completion date April 2, 2021

Study information
Verified date May 2021
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.

Description:

A large population of Covid 19 infected patients of different ages and severity levels will be explored by transthoracic echocardiography with measurement of myocardial functional parameters such as ejection fraction, longitudinal strain and relaxation parameters and will be compared to an uninfected population paired for age and sex. Patients with biological myocardial involvement will be followed to determine the evolution of their myocardial functional parameters during the course of the infection.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date April 2, 2021
Est. primary completion date April 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR Exclusion Criteria: - Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Global Longitudinal Strain
Electrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction

Locations
Country Name City State
France UHToulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left ventricular function Left ventricular function evaluated by global longitudinal strain Day 0
Primary Left ventricular function Left ventricular function evaluated by global longitudinal strain Day 3
Primary Left ventricular function Left ventricular function evaluated by global longitudinal strain Day 7
Secondary inflammatory biological parameters Cytokine rate Day 0
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