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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT04358952
Collaborator
(none)
122
1
11.9
10.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Global Longitudinal Strain

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
122 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients
Actual Study Start Date :
Apr 4, 2020
Actual Primary Completion Date :
Apr 2, 2021
Actual Study Completion Date :
Apr 2, 2021

Arms and Interventions

Arm Intervention/Treatment
COVID + patients

Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

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

Outcome Measures

Primary Outcome Measures

  1. Left ventricular function [Day 0]

    Left ventricular function evaluated by global longitudinal strain

  2. Left ventricular function [Day 3]

    Left ventricular function evaluated by global longitudinal strain

  3. Left ventricular function [Day 7]

    Left ventricular function evaluated by global longitudinal strain

Secondary Outcome Measures

  1. inflammatory biological parameters [Day 0]

    Cytokine rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UHToulouse Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Vincent MINVILLE, PU-PH, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04358952
Other Study ID Numbers:
  • RC31/20/0117
  • 2020-A00852-37
First Posted:
Apr 24, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2021