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

27 juli 2021 uppdaterad av: Groupe Hospitalier Mutualiste de Grenoble

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Grenoble, Frankrike, 38028
        • Groupe Hospitalier Mutualiste de Grenoble

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Hjärt- och lungansträngningstest
  • Cardiac diagnostic test
  • CPX test

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assess the evolution of cardiovascular function of patients included in the SCArabée program
Tidsram: At inclusion, and 6 month after inclusion
Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests
At inclusion, and 6 month after inclusion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assess the evolution of the patient's physical activity
Tidsram: At inclusion, and 6 month after inclusion
Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
At inclusion, and 6 month after inclusion
Assess the evolution of cardiac function
Tidsram: At inclusion, and 6 month after inclusion
Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
At inclusion, and 6 month after inclusion
Assess the evolution of perceived level of anxiety
Tidsram: At inclusion, and 6 month after inclusion
Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
At inclusion, and 6 month after inclusion
Assess the evolution of global quality of life
Tidsram: At inclusion, and 6 month after inclusion
Endpoint : Score of the 12-Item Short Form Health Survey (SF-12) filled by the patient
At inclusion, and 6 month after inclusion
Assess the evolution of weight
Tidsram: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
At inclusion, and 6 month after inclusion
Assess the evolution of fat mass
Tidsram: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
At inclusion, and 6 month after inclusion
Assess the evolution of visceral fat mass
Tidsram: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
At inclusion, and 6 month after inclusion
Assess the evolution of muscular mass
Tidsram: At inclusion, and 6 month after inclusion
Measured during a bioelectrical impedance analysis
At inclusion, and 6 month after inclusion
Assess the evolution of Body Mass Index
Tidsram: At inclusion, and 6 month after inclusion
At inclusion, and 6 month after inclusion
Assess the evolution of tobacco consumption
Tidsram: 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
At inclusion, and 6 month after inclusion

Samarbetspartners och utredare

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Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 januari 2019

Primärt slutförande (Faktisk)

15 december 2020

Avslutad studie (Faktisk)

15 december 2020

Studieregistreringsdatum

Först inskickad

11 september 2018

Först inskickad som uppfyllde QC-kriterierna

12 september 2018

Första postat (Faktisk)

13 september 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 juli 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2021

Senast verifierad

1 juli 2021

Mer information

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