Cardiovascular Complications and COVID-19 (CovCardioVasc-Study) (CovCardioVasc)

November 23, 2020 updated by: Centre Hospitalier Universitaire de Nice

Cardiovascular Complications in Patients With COVID-19

Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

100

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

      • Cannes, France, 06400
      • Dijon, France
        • Recruiting
        • CHU de DIJON
      • Draguignan, France, 83300
      • Grasse, France, 06130
      • Neuilly, France
      • Nice, France, 06200
        • Recruiting
        • CHU de Nice
        • Contact:
      • Paris, France, 75014
        • Recruiting
        • Hôpitaux Universitaires Paris Centre - Hôpital Cochin
        • Contact:
        • Sub-Investigator:
          • Jonathan MAREY
      • Reims, France

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive care unit, hospital ward

Description

Inclusion Criteria:

- All consecutive patients with COVID-19 infection admitted to the ICU or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included

Exclusion Criteria:

- Patients under 18 years

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
Patients with cardiovascular complications
Patients presenting with cardiomyopathies or venous thromboembolism
Patients without cardiovascular complications
Patients without cardiomyopathies or venous thromboembolism
Intensive Care Unit patients
Patients admitted in intensive care unit
Hospital Ward patients
Patients admitted in hospital ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the incidence of cardiomyopathies and venous thromboembolism
Time Frame: 28 days
Incidence of cardiomyopathies and/or venous thromboembolism at day 28
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
Incidence of mortality at day 28
28 days
Duration of mechanical ventilation
Time Frame: hospitalisation duration
Number of day of using mechanical ventilation for each patients
hospitalisation duration
Shock
Time Frame: hospitalisation duration
Incidence of shock during hospitalisation
hospitalisation duration
length of stay
Time Frame: hospitalisation duration
Number of day at hospital
hospitalisation duration
Mechanical ventilation
Time Frame: hospitalisation duration
Setting up or not of mechanical ventilation
hospitalisation duration
Renal replacement therapy
Time Frame: hospitalisation duration
Administration or not of renal replacement therapy
hospitalisation duration

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Denis DOYEN, CHU de NICE - Archet 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

February 28, 2020

Primary Completion (ANTICIPATED)

August 31, 2021

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (ACTUAL)

April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data sharing plan has been established.

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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