Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program (SCArabée)
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|ClinicalTrials.gov Identifier: NCT03669211|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Diagnostic Test: Cardiac stress test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 7, 2019|
|Estimated Primary Completion Date :||February 7, 2020|
|Estimated Study Completion Date :||February 7, 2020|
|Experimental: Cardiac stress test||
Diagnostic Test: Cardiac stress test
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.
- Assess the evolution of cardiovascular function of patients included in the SCArabée program [ Time Frame: At inclusion, and 6 month after inclusion ]Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests
- Assess the evolution of the patient's physical activity [ Time Frame: At inclusion, and 6 month after inclusion ]Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
- Assess the evolution of cardiac function [ Time Frame: At inclusion, and 6 month after inclusion ]Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
- Assess the evolution of perceived level of anxiety [ Time Frame: At inclusion, and 6 month after inclusion ]Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
- Assess the evolution of global quality of life [ 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
- Assess the evolution of weight [ Time Frame: At inclusion, and 6 month after inclusion ]Measured during a bioelectrical impedance analysis
- Assess the evolution of fat mass [ Time Frame: At inclusion, and 6 month after inclusion ]Measured during a bioelectrical impedance analysis
- Assess the evolution of visceral fat mass [ Time Frame: At inclusion, and 6 month after inclusion ]Measured during a bioelectrical impedance analysis
- Assess the evolution of muscular mass [ Time Frame: At inclusion, and 6 month after inclusion ]Measured during a bioelectrical impedance analysis
- Assess the evolution of Body Mass Index [ Time Frame: At inclusion, and 6 month after inclusion ]
- Assess the evolution of tobacco consumption [ 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
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): NCT03669211
|Contact: Adrien Monard||(0)4 76 70 70 22 ext +firstname.lastname@example.org|
|Groupe Hospitalier Mutualiste de Grenoble||Recruiting|
|Grenoble, France, 38028|
|Contact: Adrien Monard 04 76 70 70 22 ext +33 email@example.com|
|Principal Investigator: Jean Pellet, MD, Phd|