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

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ClinicalTrials.gov Identifier: NCT04335162
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
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.

Condition or disease
COVID Acute Coronary Syndrome Myocardial Infarction Myocarditis Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Complications in Patients With COVID-19
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Determine the incidence of cardiomyopathies and venous thromboembolism [ Time Frame: 28 days ]
    Incidence of cardiomyopathies and/or venous thromboembolism at day 28


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
    Incidence of mortality at day 28

  2. Duration of mechanical ventilation [ Time Frame: hospitalisation duration ]
    Number of day of using mechanical ventilation for each patients

  3. Shock [ Time Frame: hospitalisation duration ]
    Incidence of shock during hospitalisation

  4. length of stay [ Time Frame: hospitalisation duration ]
    Number of day at hospital

  5. Mechanical ventilation [ Time Frame: hospitalisation duration ]
    Setting up or not of mechanical ventilation

  6. Renal replacement therapy [ Time Frame: hospitalisation duration ]
    Administration or not of renal replacement therapy


Biospecimen Retention:   Samples Without DNA
whole blood

Eligibility Criteria
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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
Sampling Method:   Non-Probability Sample
Study Population
Intensive care unit, hospital ward
Criteria

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

Contacts and Locations
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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): NCT04335162


Contacts
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Contact: Denis DOYEN 0033492035510 doyen.d@chu-nice.fr

Locations
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France
Centre Hospitalier de Cannes Recruiting
Cannes, France, 06400
Contact: Pierre-Marie BERTRAND       PM.BERTRAND@ch-cannes.fr   
Contact: Alexandre ROBERT       A.ROBERT@ch-cannes.fr   
CHU de Dijon Recruiting
Dijon, France
Contact: Belaid BOUHEMAD       belaid_bouhemad@hotmail.com   
Centre Hospitalier de Draguignan Recruiting
Draguignan, France, 83300
Contact: Andres Jurado       andres.jurado@wanadoo.fr   
Centre Hospitalier de Grasse Recruiting
Grasse, France, 06130
Contact: Pierre-Marie Bertrand       pm.bertrand@ch-cannes.fr   
Contact: Alexandre Robert       a.robert@ch-cannes.fr   
Clinique Ambroise-Paré Recruiting
Neuilly, France
Contact: Lee NGUYEN       nguyen.lee@icloud.com   
CHU de Nice Recruiting
Nice, France, 06200
Contact: Denis DOYEN    0033492035510,    doyen.d@chu-nice.fr   
Hôpitaux Universitaires Paris Centre - Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Mathieu Jozwiak    0033158412661    mathieu.jozwiak@aphp.fr   
Sub-Investigator: Jonathan MAREY         
CHU de REIMS Recruiting
Reims, France
Contact: Vincent DUPONT       vdupont@chu-reims.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Denis DOYEN CHU de NICE - Archet 1
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04335162    
Other Study ID Numbers: 20reamedcovid01
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no data sharing plan has been established.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Myocardial Infarction
Thrombosis
Acute Coronary Syndrome
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Myocarditis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Cardiomyopathies