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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Grenoble, Frankrig, 38028
        • Groupe hospitalier mutualiste de Grenoble

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • Kardiopulmonal træningstest
  • Cardiac diagnostic test
  • CPX test

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess the evolution of cardiovascular function of patients included in the SCArabée program
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess the evolution of the patient's physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At inclusion, and 6 month after inclusion
At inclusion, and 6 month after inclusion
Assess the evolution of tobacco consumption
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. januar 2019

Primær færdiggørelse (Faktiske)

15. december 2020

Studieafslutning (Faktiske)

15. december 2020

Datoer for studieregistrering

Først indsendt

11. september 2018

Først indsendt, der opfyldte QC-kriterier

12. september 2018

Først opslået (Faktiske)

13. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2018/06-JPE-GHMG

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Akut koronarsyndrom

Kliniske forsøg med Cardiac stress test

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