- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Valencia, España, 46010
- Juan Sanchis
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: Control
Conventional strategy consisting only of the usual care by the cardiologist
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change on frailty status according to the Fried scale
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15/00837
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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