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Clinical Trials/NCT03669211
NCT03669211
Completed
Not Applicable

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

Groupe Hospitalier Mutualiste de Grenoble1 site in 1 country30 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Enrollment
30
Locations
1
Primary Endpoint
Assess the evolution of cardiovascular function of patients included in the SCArabée program
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
December 15, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Groupe Hospitalier Mutualiste de Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Assess the evolution of global quality of life(At inclusion, and 6 month after inclusion)
  • Assess the evolution of muscular mass(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 the patient's physical activity(At inclusion, and 6 month after inclusion)
  • Assess the evolution of weight(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 visceral fat mass(At inclusion, and 6 month after inclusion)
  • Assess the evolution of tobacco consumption(At inclusion, and 6 month after inclusion)
  • Assess the evolution of fat mass(At inclusion, and 6 month after inclusion)

Study Sites (1)

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