Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Cardiac stress test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 or older Patient with newly diagnosed or recurring Acute Coronary Syndrome, or presenting a coronary heart disease detected on ischemia test and stented Patient included in the SCArabée therapeutic education program Patient assessed stable on the basis of a clinical examination, or exercise test, or ultrasound data Patient in physical capacity to perform a cardiorespiratory test Patient giving free, informed and written consent Patient affiliated to the social security system Exclusion Criteria: Impossibility to submit to follow-up of the study for geographical social or psychological reasons Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (corresponds to all persons protected): pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person making the subject of a legal protection measure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac stress test<br> | Diagnostic Test: Cardiac stress test<br>* 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.<br>* Other names: CPX test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the evolution of cardiovascular function of patients included in the SCArabée program | Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests | At inclusion, and 6 month after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the evolution of the patient's physical activity | Endpoint : Score of the Ricci and Gagnon questionnaire filled by the patient | At inclusion, and 6 month after inclusion | 
| Assess the evolution of cardiac function | Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests | At inclusion, and 6 month after inclusion | 
| Assess the evolution of perceived level of anxiety | Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient | At inclusion, and 6 month after inclusion | 
| Assess the evolution of global quality of life | Endpoint : Score of the 12-Item Short Form Health Survey (SF-12) filled by the patient | At inclusion, and 6 month after inclusion | 
| Assess the evolution of weight | Measured during a bioelectrical impedance analysis | At inclusion, and 6 month after inclusion | 
| Assess the evolution of fat mass | Measured during a bioelectrical impedance analysis | At inclusion, and 6 month after inclusion | 
| Assess the evolution of visceral fat mass | Measured during a bioelectrical impedance analysis | At inclusion, and 6 month after inclusion | 
| Assess the evolution of muscular mass | Measured during a bioelectrical impedance analysis | At inclusion, and 6 month after inclusion | 
| Assess the evolution of Body Mass Index |  | At inclusion, and 6 month after inclusion | 
| Assess the evolution of tobacco consumption | 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 | At inclusion, and 6 month after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic education, Cardiac stress test