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Cardiovascular Consequences After COVID-19

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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

Tracking Information
First Submitted Date June 26, 2020
First Posted Date June 30, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date June 23, 2020
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Consequences After COVID-19
Official Title The CardioPostCovid Study: Cardiovascular Consequences After COVID-19
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cardiovascular Consequences After an Episode of COVID 19
Intervention 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
Study Groups/Cohorts 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.
Intervention: Other: Infectious Disease and Cardiology Clinical Consultations
Publications * Not Provided

*   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: June 26, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Franck THUNY, MD franck.thuny@ap-hm.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04452630
Other Study ID Numbers 2020-36
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
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date June 2020