Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Geneva Covid-19 CVD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384029
Recruitment Status : Active, not recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
François MACH, University Hospital, Geneva

Brief Summary:
In this study, the investigators propose to analyse the clinical data of all patients admitted in Geneva University Hospitals (HUG) or in a care center in Geneva who are diagnosed with COVID-19. CVD being one of the most important risk factors for developing a severe form of the disease, the investigators will explore the prognosis and clinical outcomes of those patients according to their CVD history as well as newly onset CVD during hospitalization. Moreover, as further evidence is needed on the use of renin-angiotensin-aldosterone system (RAAS) inhibitors for SARS-CoV-2 infected patients, the investigators will study prognosis and outcomes according to the patients' medications. Finally, the investigators propose to evaluate hospital length of stay and cost. The aim, therefore, is to collect information and scientific evidence from patients hospitalized and diagnosed positive for COVID-19, in order to evaluate if previous (or newly onset) CVD may influence outcomes and costs.

Condition or disease Intervention/treatment
COVID CVD Other: Covid-19 + patients

Detailed Description:

Hypothesis:

COVID-19+ hospitalized patients with preexisting CVD or newly onset CVD at time of hospitalization have different clinical outcomes compared to those without CVD and COVID-19+.

Objectives:

The primary aim of this study is to gather observational data, starting from February 1st 2020 until the end of the pandemic, to compare clinical outcomes COVID+ hospitalized patients at HUG or in a care center in Geneva with pre-existing or newly onset CVD, to COVID+ hospitalized patients at HUG or in a care center in Geneva without pre-existing CVD.

The secondary aims of this study are:

  • To determine the association between COVID-19 disease and CVD, based on: age, previous CV diseases, CV risks factors, CV medications (e.g. ACE Inhibitors or angiotensin II receptor antagonists)
  • To explore CVD profiles that may influence COVID-19 disease outcomes
  • To determine the cause of death in CVD patients (either with preexisting CVD or newly diagnosed with CVD)
  • To understand the vulnerability of the myocardium (new event of either heart failure, acute coronary syndrome, arrhythmia, myocarditis) in patients with COVID-19 disease.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Retrospective Observational Study to Compare the Short, Mid- and Long-term Prognosis and Outcomes of SRAS-CoV-2 Infected Hospitalized Patients With Cardiovascular Disease (CVD) to SARS-CoV-2 Infected Hospitalized Patients Without CVD: The Geneva Covid-19 CVD Study
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Intervention Details:
  • Other: Covid-19 + patients
    all the patients hospitalized in Geneva and SARS-Cov2 positive


Primary Outcome Measures :
  1. mobidity discharge [ Time Frame: 0 days after hospitalization ]
    To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.

  2. mobidity at 30 days [ Time Frame: 30 days after hospitalization ]
    To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.

  3. mobidity 1 year after hospitalization [ Time Frame: 1 year after hospitalization ]
    To compare morbidity 1 year after hospitalization stay in COVID-19+ patients with or without preexisting CVD.

  4. mortality discharge [ Time Frame: 0 days after hospitalization ]
    To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.

  5. mortality 30 days after hospitalization [ Time Frame: 30 days after hospitalization ]
    To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.

  6. mortality 1 year after hospitalization [ Time Frame: 1 year after hospitalization ]
    To compare mortality 1 year after hospital stay in COVID-19+ patients with or without preexisting CVD.


Secondary Outcome Measures :
  1. Clinical outcomes according to medication at admission [ Time Frame: 0 days after hospitalization ]
    Clinical outcomes according to medication at admission evaluated at hospital discharge

  2. Clinical outcomes according to medication at admission [ Time Frame: 30 days after hospitalization ]
    Clinical outcomes according to medication at admission evaluated 30 days after hospitalization

  3. Clinical outcomes according to medication at admission [ Time Frame: 1 year after hospitalization ]
    1 year after hospitalization

  4. Clinical outcomes related to preexisting cardiovascular risk factors at admission [ Time Frame: 0 days after hospitalization ]
    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated after hospital discharge

  5. Clinical outcomes related to preexisting cardiovascular risk factors at admission [ Time Frame: 30 days after hospitalization ]
    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 30 days after hospital discharge

  6. Clinical outcomes related to preexisting cardiovascular risk factors at admission [ Time Frame: 1 year after hospitalization ]
    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 1 year after hospitalization

  7. New onset of CVD induced by COVID-19 disease [ Time Frame: 0 days after hospitalization ]
    New onset of CVD induced by COVID-19 disease at discharge

  8. New onset of CVD induced by COVID-19 disease [ Time Frame: 30 days after hospitalization ]
    New onset of CVD induced by COVID-19 disease evaluated 30 days after hospitalization

  9. New onset of CVD induced by COVID-19 disease [ Time Frame: 1 year after hospitalization ]
    New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization

  10. Cost of hospital stay [ Time Frame: 0 days after hospitalization ]
    Cost of hospital stay

  11. Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis). [ Time Frame: 30 days after hospitalization ]
    Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

  12. Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis). [ Time Frame: 1 year after hospitalization ]
    Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This observational study will include male and female patients hospitalized with a COVID+ diagnosis at the HUG or in a care center in Geneva.
Criteria

Inclusion Criteria:

  • Subject is ≥18 years of age.
  • Patient diagnosed SARS-CoV-2 positive at time of hospitalization.
  • In case of the subject accepting the follow-up at 30 days and 1 year, Signed Patient Informed Consent (PIC) form

Exclusion Criteria:

  • Patients unwilling to provide informed consent for the follow-up.

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): NCT04384029


Locations
Layout table for location information
Switzerland
Geneva University Hospital (HUG)
Geneva, Switzerland, 1211
Sponsors and Collaborators
François MACH
Layout table for additonal information
Responsible Party: François MACH, Professor François MACH, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04384029    
Other Study ID Numbers: CCER-2020-00610
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No