Cardiovascular Consequences After COVID-19

June 26, 2020 updated by: Assistance Publique Hopitaux De Marseille

The CardioPostCovid Study: Cardiovascular Consequences After COVID-19

The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more frequent than in other viral respiratory infections, probably due to a singular pathophysiology of this coronavirus.

The lack of characterization of cardiovascular damages linked to Covid-19 could have medium and long-term consequences on the prognosis of patients. This problematic could lead to a second major public health problem linked to Covid-19 and it is therefore crucial to keep monitoring and screening patients at risk.

In this context of emerging infectious diseases, of poorly characterized cardiovascular damages during infection and of absence of data on the long-term evolution of the infection, the investigators propose to carry out a prospective and observational cohort study focused on the evaluation and the systematic cardiovascular follow up of patients who survived an episode of Covid-19, regardless of their cardiovascular profiles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13005
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients can be enrolled in this study if they survived to an episode of Covid-19, whether they were hospitalized or not. They must have been diagnosed Covid19 positive according to international recommendations between January 24, 2020 (date of the first case declared in mainland France) and June 30, 2020. They will be offered to participate to the study during the systematic consultations set up at the Nord Hospital for follow-up patients who have been infected.

Description

Inclusion Criteria:

• All adults affiliated to social security attending the post-Covid follow-up consultation, having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.

Exclusion Criteria:

  • Age <18 years old
  • Major under guardianship or curatorship
  • Absence of non-opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid 19 Patients
patients having presented an episode of Covid-19 diagnosed by at least one positive nasopharyngeal RT-PCR test for SARS-Cov-2 and considered recovered.
Other: Infectious Disease and Cardiology Clinical Consultations
Infectious Diseases and Cardiology Clinical Consultations at 1 month and 12 months of recovery from an episode of Covid-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of at least one clinical, biological and/or imaging cardiovascular anomaly within 1 month of recovering
Time Frame: 1 month
Describe clinical, biological and imaging cardiovascular data 1 month after recovery from an episode of Covid-19
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Anticipated)

July 23, 2020

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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