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

NCT03669211 | Completed

• 1 other identifier: 2018/06-JPE-GHMG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Therapeutic education; Cardiac stress test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Assess the evolution of the patient's physical activity

  At inclusion, and 6 month after inclusion

• Assess the evolution of cardiac function

  At inclusion, and 6 month after inclusion

• Assess the evolution of perceived level of anxiety

  At inclusion, and 6 month after inclusion

• Assess the evolution of global quality of life

  At inclusion, and 6 month after inclusion

• Assess the evolution of weight

  At inclusion, and 6 month after inclusion

Study Arms (1)

Cardiac stress test

EXPERIMENTAL

Diagnostic Test: Cardiac stress test

Interventions

Cardiac stress test DIAGNOSTIC_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.

Also known as: Cardiac diagnostic test, Cardiopulmonary exercise test, CPX test

Cardiac stress test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

Related Publications (14)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: January 7, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

FR (1)