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

G

Groupe Hospitalier Mutualiste de Grenoble

Status

Completed

Conditions

Acute Coronary Syndrome

Treatments

Diagnostic Test: Cardiac stress test

Study type

Interventional

Funder types

Other

Identifiers

NCT03669211
2018/06-JPE-GHMG

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Cardiac stress test
Experimental group
Treatment:
Diagnostic Test: Cardiac stress test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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