REACARDIOCOVID: Impact of COVID-19 on the Benefit of Cardiac Rehabilitation

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04513964
Collaborator
(none)
0
16.9

Study Details

Study Description

Brief Summary

The COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response.

Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities.

On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form.

Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation.

Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.).

It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type.

Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement.

The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Impact of COVID-19 on the Benefit of Cardiac Rehabilitation
    Actual Study Start Date :
    Nov 1, 2020
    Actual Primary Completion Date :
    Mar 30, 2022
    Actual Study Completion Date :
    Mar 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Patient not suffering from COVID-19

    COVID-19

    Patient who has been infected with COVID-19 with suggestive signs and authentication by PCR or thoracic CT or serology

    Outcome Measures

    Primary Outcome Measures

    1. Impact of COVID-19 on exercise capacity gain after cardiovascular rehabilitation [Month 3]

      This outcome corresponds to the difference between the average gain in exercise capacity after cardiac rehabilitation between the two groups of patients Control and COVID-19.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient aged ≥ 18 years

    • Patient referred for outpatient cardiovascular rehabilitation in one of the participating centers between 02/01/2020 and 12/31/2020

    • French-speaking patient

    Exclusion Criteria:
    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under legal protection

    • Patient objecting to the use of their data as part of this research

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Study Director: DUC Philippe, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04513964
    Other Study ID Numbers:
    • READCARDIOCOVID
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022