- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03669211
Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program (SCArabée)
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Grenoble, 프랑스, 38028
- Groupe Hospitalier Mutualiste de Grenoble
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Assess the evolution of cardiovascular function of patients included in the SCArabée program
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Assess the evolution of the patient's physical activity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At inclusion, and 6 month after inclusion
|
At inclusion, and 6 month after inclusion
|
|
Assess the evolution of tobacco consumption
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.
- Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.
- Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34. doi: 10.1001/archinte.166.21.2329.
- Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
- Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.
- Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labeque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Gueret P, Belle L, Aissaoui N, Ferrieres J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.
- Kotseva K, De Bacquer D, De Backer G, Ryden L, Jennings C, Gyberg V, Abreu A, Aguiar C, Conde AC, Davletov K, Dilic M, Dolzhenko M, Gaita D, Georgiev B, Gotcheva N, Lalic N, Laucevicius A, Lovic D, Mancas S, Milicic D, Oganov R, Pajak A, Pogosova N, Reiner Z, Vulic D, Wood D, On Behalf Of The Euroaspire Investigators. Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. Eur J Prev Cardiol. 2016 Dec;23(18):2007-2018. doi: 10.1177/2047487316667784. Epub 2016 Sep 27.
- Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labeque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrieres J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.
- Fox KA, Carruthers KF, Dunbar DR, Graham C, Manning JR, De Raedt H, Buysschaert I, Lambrechts D, Van de Werf F. Underestimated and under-recognized: the late consequences of acute coronary syndrome (GRACE UK-Belgian Study). Eur Heart J. 2010 Nov;31(22):2755-64. doi: 10.1093/eurheartj/ehq326. Epub 2010 Aug 30.
- Pavy B, Barbet R, Carre F, Champion C, Iliou MC, Jourdain P, Juilliere Y, Monpere C, Brion R; Working Group of Exercise Rehabilitation and Sport; Therapeutic Education Commission of the French Society of Cardiology. Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology. Arch Cardiovasc Dis. 2013 Dec;106(12):680-9. doi: 10.1016/j.acvd.2013.10.002. Epub 2013 Nov 15.
- Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D; GOSPEL Investigators. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008 Nov 10;168(20):2194-204. doi: 10.1001/archinte.168.20.2194.
- Wasserman K, Hansen JE, Sue DY, Whipp BJ, Froelicher VF. Principles of Exercise Testing and Interpretation. Journal of Cardiopulmonary Rehabilitation and Prevention. avr 1987;7(4):189.
- Cerretelli P. Traité de physiologie de l'exercice et du sport. Elsevier Masson; 2002. 504 p.
- Wilmore JH, Costill DL, Kenney L. Physiologie du sport et de l'exercice. De Boeck Superieur; 2017. 644 p.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
급성관상동맥증후군에 대한 임상 시험
-
Chinese Academy of Medical Sciences, Fuwai HospitalMedtronic; CCRF Consulting Co., Ltd.빼는Transradial-transfemoral Coronary Interventions 비교
-
CCRF Consulting Co., Ltd.Peking University First Hospital; Terumo Medical(shanghai) Co.,Ltd.알려지지 않은심장 또는 뇌혈관 질환 무료 요금 | Transradial-transfemoral Coronary Interventions 비교중국
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Icahn School of Medicine at Mount SinaiNational Institute on Deafness and Other Communication Disorders (NIDCD)완전한
-
Basaksehir Cam & Sakura Şehir Hospital완전한
-
China Medical University Hospital알려지지 않은
-
Wolfson Medical Center빼는Ovarian Hyperstimulation Syndrome(OHSS)의 위험 감소를 위한 Coasting에 대한 GnRH 길항제의 증량 투여
-
Jazz Pharmaceuticals모병결절성 경화증 복합 환자의 발작 | Dravet Syndrome 참가자의 발작 | 레녹스-가스토 증후군 참가자의 발작미국
-
Cure CMD모병Emery-Dreifuss 근이영양증 | 선천성 근무력증 증후군 | 림거들 근이영양증 | ITGA7(인테그린 알파-7) 결핍을 동반한 선천성 근이영양증 | 알파-디스트로글리칸병증(심각한 간질을 동반한 디스트로글리칸의 선천성 근이영양증 및 비정상적인 글리코실화) | 알파-디스트로글리칸병증(TRAPPC11 돌연변이로 인한 지방간 및 영아 발병 백내장을 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸의 저당화를 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸 및 간질의 저당화를 동반한 선천성 근이영양증) | 알파-디스트로글리칸병증(디스트로글리칸병증... 그리고 다른 조건미국
Cardiac stress test에 대한 임상 시험
-
Medtronic Cardiac Rhythm and Heart Failure완전한
-
University College, LondonUniversity of Roehampton완전한우울증 | 스트레스, 심리적 | 불안
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic International Trading Sarl완전한
-
Uppsala University HospitalMedtronic; Swedish Heart Lung Foundation알려지지 않은
-
PATHUnited States Agency for International Development (USAID); Kintampo Health Research Centre...완전한