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.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Valencia, Espanha, 46010
- Juan Sanchis
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: Control
Conventional strategy consisting only of the usual care by the cardiologist
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change on frailty status according to the Fried scale
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
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Mais Informações
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Palavras-chave
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Outros números de identificação do estudo
- 15/00837
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