Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program (SCArabée)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac stress test
Sponsored by
About this trial
This is an interventional other trial for Acute Coronary Syndrome focused on measuring Therapeutic education, Cardiac stress test
Eligibility Criteria
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
Sites / Locations
- Groupe Hospitalier Mutualiste de Grenoble
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac stress test
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Assess the evolution of the patient's physical activity
Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
Assess the evolution of cardiac function
Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
Assess the evolution of perceived level of anxiety
Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
Assess the evolution of global quality of life
Endpoint : Score of the 12-Item Short Form Health Survey (SF-12) filled by the patient
Assess the evolution of weight
Measured during a bioelectrical impedance analysis
Assess the evolution of fat mass
Measured during a bioelectrical impedance analysis
Assess the evolution of visceral fat mass
Measured during a bioelectrical impedance analysis
Assess the evolution of muscular mass
Measured during a bioelectrical impedance analysis
Assess the evolution of Body Mass Index
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
Full Information
NCT ID
NCT03669211
First Posted
September 11, 2018
Last Updated
July 27, 2021
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
Fondation de l'Avenir
1. Study Identification
Unique Protocol Identification Number
NCT03669211
Brief Title
Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program
Acronym
SCArabée
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Collaborators
Fondation de l'Avenir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Therapeutic education, Cardiac stress test
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac stress test
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac stress test
Other Intervention Name(s)
Cardiac diagnostic test, Cardiopulmonary exercise test, CPX test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess the evolution of cardiovascular function of patients included in the SCArabée program
Description
Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests
Time Frame
At inclusion, and 6 month after inclusion
Secondary Outcome Measure Information:
Title
Assess the evolution of the patient's physical activity
Description
Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of cardiac function
Description
Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of perceived level of anxiety
Description
Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of global quality of life
Description
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
Title
Assess the evolution of weight
Description
Measured during a bioelectrical impedance analysis
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of fat mass
Description
Measured during a bioelectrical impedance analysis
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of visceral fat mass
Description
Measured during a bioelectrical impedance analysis
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of muscular mass
Description
Measured during a bioelectrical impedance analysis
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of Body Mass Index
Time Frame
At inclusion, and 6 month after inclusion
Title
Assess the evolution of tobacco consumption
Description
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
Time Frame
At inclusion, and 6 month after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
ZIP/Postal Code
38028
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program
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