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Cardiovascular Consequences After COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452630
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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.


Condition or disease Intervention/treatment
Cardiovascular Consequences After an Episode of COVID 19 Other: Infectious Disease and Cardiology Clinical Consultations

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CardioPostCovid Study: Cardiovascular Consequences After COVID-19
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : July 23, 2020
Estimated Study Completion Date : November 30, 2021

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452630


Contacts
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Contact: Franck THUNY, MD franck.thuny@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Franck THUNY, MD       franck.thuny@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04452630    
Other Study ID Numbers: 2020-36
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No