- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04335162
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
Status
Unknown
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
- Name: Denis DOYEN
- Phone Number: 0033492035510
- Email: doyen.d@chu-nice.fr
Study Locations
-
-
-
Cannes, France, 06400
- Recruiting
- Centre hospitalier de Cannes
-
Contact:
- Alexandre Robert
- Email: a.robert@ch-cannes.fr
-
Dijon, France
- Recruiting
- CHU de DIJON
-
Draguignan, France, 83300
- Recruiting
- Centre hospitalier de Draguignan
-
Contact:
- Andres Jurado
- Email: andres.jurado@wanadoo.fr
-
Grasse, France, 06130
- Recruiting
- Centre hospitalier de Grasse
-
Contact:
- Alexandre Robert
- Email: a.robert@ch-cannes.fr
-
Neuilly, France
- Recruiting
- Clinique Ambroise-Paré
-
Contact:
- Lee NGUYEN
- Email: nguyen.lee@icloud.com
-
Nice, France, 06200
- Recruiting
- CHU de Nice
-
Contact:
- Denis DOYEN
- Phone Number: 0033492035510,
- Email: doyen.d@chu-nice.fr
-
Paris, France, 75014
- Recruiting
- Hôpitaux Universitaires Paris Centre - Hôpital Cochin
-
Contact:
- Mathieu Jozwiak
- Phone Number: 0033158412661
- Email: mathieu.jozwiak@aphp.fr
-
Sub-Investigator:
- Jonathan MAREY
-
Reims, France
- Recruiting
- CHU de Reims
-
Contact:
- Vincent DUPONT
- Email: vdupont@chu-reims.fr
-
-
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
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Cardiomyopathies
- Infarction
- Myocardial Infarction
- Embolism
- Myocarditis
- Thrombosis
- Venous Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Acute Coronary Syndrome
- Pulmonary Embolism
Other Study ID Numbers
- 20reamedcovid01
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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