- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02715453
Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction (FRAMIP)
Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction.
Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Valencia, 스페인, 46010
- Juan Sanchis
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Admission for acute myocardial infarction and survivors in the hospitalization phase
- Age =>70 years
- Prefrail or frail status (Fried scale =>1 points)
Exclusion Criteria:
- Cognitive impairment (Pfeiffer test)
- Severe concomitant disease that could hamper the participation in the study
- Patient refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention on frailty
Intervention on frailty in addition to the usual care by the cardiologist.
A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty
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Multidisciplinary team (physicians, nurses, physiotherapists, and nutritionists):
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간섭 없음: Control
Conventional strategy consisting only of the usual care by the cardiologist
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change on frailty status according to the Fried scale
기간: 3 months and 1 year
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Points in the Fried scale
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3 months and 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Total cardiac (cardiac death, reinfarction, postdischarge revascularization, readmission for acute heart failure, readmission for other cardiac cause) and non-cardiac (all-cause mortality or readmission for non-cardiac cause) clinical events
기간: Up to 3 years
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Number of participants with the events
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Up to 3 years
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All-cause mortality
기간: Up to 3 years
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Number of participants dead
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Up to 3 years
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Ischemic events (reinfarction or postdischarge revascularization)
기간: Up to 3 years
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Number of participants with reinfarction (readmission for chest pain with troponin elevation) or postdischarge revascularization (percutaneous coronary intervention or coronary surgery)
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Up to 3 years
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Readmission for acute heart failure
기간: Up to 3 years
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Number of participants with readmission for acute heart failure
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Up to 3 years
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Readmission for non-cardiac causes
기간: Up to 3 years
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Number of participants with readmission for non-cardiac cause
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Up to 3 years
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Change of Quality of life (EUROQOL)
기간: 3 months and 1 year
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EUROQOL test
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3 months and 1 year
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Change of Functional capacity (walk distance test)
기간: 3 months and 1 year
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Distance walked during 6 minutes
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3 months and 1 year
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Change of Nutritional status (Mini Nutritional Assessment)
기간: 3 months and 1 year
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Mini Nutritional Assessment Test
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3 months and 1 year
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Sanchis J, Nunez E, Ruiz V, Bonanad C, Fernandez J, Cauli O, Garcia-Blas S, Mainar L, Valero E, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Nunez J. Usefulness of Clinical Data and Biomarkers for the Identification of Frailty After Acute Coronary Syndromes. Can J Cardiol. 2015 Dec;31(12):1462-8. doi: 10.1016/j.cjca.2015.07.737. Epub 2015 Aug 21.
- Sanchis J, Bonanad C, Ruiz V, Fernandez J, Garcia-Blas S, Mainar L, Ventura S, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Bertomeu-Gonzalez V, Nunez E, Nunez J. Frailty and other geriatric conditions for risk stratification of older patients with acute coronary syndrome. Am Heart J. 2014 Nov;168(5):784-91. doi: 10.1016/j.ahj.2014.07.022. Epub 2014 Jul 30.
- Sanchis J, Sastre C, Ruescas A, Ruiz V, Valero E, Bonanad C, Garcia-Blas S, Fernandez-Cisnal A, Gonzalez J, Minana G, Nunez J. Randomized Comparison of Exercise Intervention Versus Usual Care in Older Adult Patients with Frailty After Acute Myocardial Infarction. Am J Med. 2021 Mar;134(3):383-390.e2. doi: 10.1016/j.amjmed.2020.09.019. Epub 2020 Oct 24.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
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