Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
NCT Number: NCT03669211
Coronary artery disease is defined as a disease of the arteries that vascularize the heart, resulting in myocardial ischemia, i.e. insufficient blood supply to the heart muscle. Eventually, it may be responsible for acute coronary syndrome that includes unstable angina (chest pain) and myocardial infarction (necrosis of the heart muscle).
The main cause of this disease is atheroma, and management involves reducing modifiable cardiovascular risk factors (sedentary lifestyle, smoking, obesity, high blood pressure, diabetes, dyslipidemia). Every year, this disease affects more than 120 000 people in France, aging 65 years on average.
In this real public health problem, there is a significant discrepancy between the excellence of the management of the acute incident and the inadequacy of the re-adaptive and educational management of the care suites. In fact, it is noted that hospitalization times are short given the progress of myocardial revascularization, associated with a low intra-hospital mortality rate, 3% but the places in rehabilitation programs ("Soins de Suite et de Réadaptation" or "SSR") are too limited (25% of the patients are included in these programs). Physical rehabilitation has proven effective for decades, with robust evidence of decreased recurrence and mortality (-20%).
At the Groupe Hospitalier Mutualiste of Grenoble, France, patients are offered two courses of treatment in post-myocardial infarction:
* A therapeutic education program: SCarabée, * A rehabilitation program (SSR) The therapeutic education program aims to help the patient identify his needs, acquire knowledge, strengthen his resources and finally develop with him a project to improve his quality of life.
SSR offers physical rehabilitation as a treatment for infarction, which improves cardiovascular function, which is assessed by the cardiorespiratory test.
Is the Scarabée therapeutic education program is sufficient to help the patient improve his physical abilities? This study aims to answer this question, by setting up a reinforced monitoring of the evolution of the cardiovascular function of the patients included in the SCArabée program, via cardiorespiratory tests. The results of this first pilot study will potentially lead to a second randomized study comparing therapeutic education associated with Adapted Physical Education versus therapeutic education alone for the improvement of cardiorespiratory functions and the quality of life of these patients.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Grenoble, 38028, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In order to assess the evolution of their cardiorespiratory function, patients will benefit from two cardiac stress test combined with VO2 study, one at inclusion in the study, and the other one 6 months later.
Other names: Cardiac diagnostic test, Cardiopulmonary exercise test, CPX test
Time frame: At inclusion, and 6 month after inclusion
Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests
Time frame: At inclusion, and 6 month after inclusion
Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
Time frame: At inclusion, and 6 month after inclusion
Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
Time frame: At inclusion, and 6 month after inclusion
Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
Time frame: At inclusion, and 6 month after inclusion
Endpoint : Score of the 12-Item Short Form Health Survey (SF-12) filled by the patient
Time frame: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
Time frame: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
Time frame: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
Time frame: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
Time frame: At inclusion, and 6 month after inclusion
Time frame: At inclusion, and 6 month after inclusion
Comparison of the number of cigarettes consumed per day between the month preceeding the Acute Coronary Syndrome event and the 6th month of follow-up
Groupe Hospitalier Mutualiste de Grenoble
Other
A Pilot, Prospective Study Assessing the Evolution of Cardiovascular Function and Quality of Life in Patients With Acute Coronary Syndrome, Included in the SCArabée Therapeutic Education Program
Acronym: SCArabée
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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