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Completed

NCT Number: NCT03669211

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cardiac diagnostic test, Cardiopulmonary exercise test, CPX test

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Mutualiste de Grenoble

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study 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

Acronym: SCArabée

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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