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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
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Groupe Hospitalier Mutualiste de Grenoble

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Diagnostic Test: Cardiac stress test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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.
Other Names:
  • Cardiac diagnostic test
  • Cardiopulmonary exercise test
  • CPX test




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Assess the evolution of weight [ Time Frame: At inclusion, and 6 month after inclusion ]
    Measured during a bioelectrical impedance analysis

  6. Assess the evolution of fat mass [ Time Frame: At inclusion, and 6 month after inclusion ]
    Measured during a bioelectrical impedance analysis

  7. Assess the evolution of visceral fat mass [ Time Frame: At inclusion, and 6 month after inclusion ]
    Measured during a bioelectrical impedance analysis

  8. Assess the evolution of muscular mass [ Time Frame: At inclusion, and 6 month after inclusion ]
    Measured during a bioelectrical impedance analysis

  9. Assess the evolution of Body Mass Index [ Time Frame: At inclusion, and 6 month after inclusion ]
  10. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Adrien Monard (0)4 76 70 70 22 ext +33 a.monard@ghm-grenoble.fr

Locations
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France
Groupe Hospitalier Mutualiste de Grenoble Recruiting
Grenoble, France, 38028
Contact: Adrien Monard    04 76 70 70 22 ext +33    a.monard@ghm-grenoble.fr   
Principal Investigator: Jean Pellet, MD, Phd         
Sponsors and Collaborators
Groupe Hospitalier Mutualiste de Grenoble
Fondation de l'Avenir

Publications:
Wasserman K, Hansen JE, Sue DY, Whipp BJ, Froelicher VF. Principles of Exercise Testing and Interpretation. Journal of Cardiopulmonary Rehabilitation and Prevention. avr 1987;7(4):189.
Cerretelli P. Traité de physiologie de l'exercice et du sport. Elsevier Masson; 2002. 504 p.
Wilmore JH, Costill DL, Kenney L. Physiologie du sport et de l'exercice. De Boeck Superieur; 2017. 644 p.

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Responsible Party: Groupe Hospitalier Mutualiste de Grenoble
ClinicalTrials.gov Identifier: NCT03669211     History of Changes
Other Study ID Numbers: 2018/06-JPE-GHMG
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Mutualiste de Grenoble:
Therapeutic education
Cardiac stress test
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases