CClinicalTrials.gg
CompletedNCT04335162CovCardioVascUpdated Apr 3, 2025

Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

An observational study in COVID, Acute Coronary Syndrome and Myocardial Infarction, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
198
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Myocarditis
  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Pulmonary Embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 198 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Intensive care unit, hospital ward

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

Exclusion Criteria:

  • Patients under 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
198 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Determine the incidence of cardiomyopathies and venous thromboembolism

    Incidence of cardiomyopathies and/or venous thromboembolism at day 28

    Time frame: 28 days

Secondary outcomes

  1. Mortality

    Incidence of mortality at day 28

    Time frame: 28 days

  2. Duration of mechanical ventilation

    Number of day of using mechanical ventilation for each patients

    Time frame: hospitalisation duration

  3. Shock

    Incidence of shock during hospitalisation

    Time frame: hospitalisation duration

  4. length of stay

    Number of day at hospital

    Time frame: hospitalisation duration

  5. Mechanical ventilation

    Setting up or not of mechanical ventilation

    Time frame: hospitalisation duration

  6. Renal replacement therapy

    Administration or not of renal replacement therapy

    Time frame: hospitalisation duration

07

Study locations

8 sites
  • Centre Hospitalier de Cannes
    Cannes, 06400, France
  • CHU de Dijon
    Dijon, France
  • Centre Hospitalier de Draguignan
    Draguignan, 83300, France
  • Centre Hospitalier de Grasse
    Grasse, 06130, France
  • Clinique Ambroise-Paré
    Neuilly, France
  • CHU de Nice
    Nice, 06200, France
  • Hôpitaux Universitaires Paris Centre - Hôpital Cochin
    Paris, 75014, France
  • CHU de REIMS
    Reims, France
08

References and documents

Publications

  • 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. PubMed 32972320 ↗

Individual participant data

Plan to share: No — no data sharing plan has been established.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04335162
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Feb 28, 2020
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021
Last update
Apr 3, 2025

Study contacts

Denis DOYEN
principal investigator · CHU de NICE - Archet 1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion