Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

NCT ID: NCT04335162

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-28

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cardiovascular complications

Patients presenting with cardiomyopathies or venous thromboembolism

No interventions assigned to this group

Patients without cardiovascular complications

Patients without cardiomyopathies or venous thromboembolism

No interventions assigned to this group

Intensive Care Unit patients

Patients admitted in intensive care unit

No interventions assigned to this group

Hospital Ward patients

Patients admitted in hospital ward

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis DOYEN

Role: PRINCIPAL_INVESTIGATOR

CHU de NICE - Archet 1

Locations

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Centre Hospitalier de Cannes

Cannes, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

Centre Hospitalier de Draguignan

Draguignan, , France

Site Status

Centre Hospitalier de Grasse

Grasse, , France

Site Status

Clinique Ambroise-Paré

Neuilly, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Hôpitaux Universitaires Paris Centre - Hôpital Cochin

Paris, , France

Site Status

CHU de REIMS

Reims, , France

Site Status

Countries

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France

References

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Jozwiak M, Dupuis C, Denormandie P, Aurenche Mateu D, Louchet J, Heme N, Mira JP, Doyen D, Dellamonica J. Right ventricular injury in critically ill patients with COVID-19: a descriptive study with standardized echocardiographic follow-up. Ann Intensive Care. 2024 Jan 23;14(1):14. doi: 10.1186/s13613-024-01248-8.

Reference Type DERIVED
PMID: 38261092 (View on PubMed)

Jozwiak M, Doyen D, Denormandie P, Goury A, Marey J, Pene F, Cariou A, Mira JP, Dellamonica J, Nguyen LS. Impact of sex differences on cardiac injury in critically ill patients with COVID-19. Respir Res. 2023 Nov 20;24(1):292. doi: 10.1186/s12931-023-02581-5.

Reference Type DERIVED
PMID: 37986157 (View on PubMed)

Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.

Reference Type DERIVED
PMID: 32972320 (View on PubMed)

Other Identifiers

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20reamedcovid01

Identifier Type: -

Identifier Source: org_study_id

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