Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction
- Conditions
- Fragility
- Interventions
- Other: Intervention on frailty
- Registration Number
- NCT02715453
- Lead Sponsor
- University of Valencia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Admission for acute myocardial infarction and survivors in the hospitalization phase
- Age =>70 years
- Prefrail or frail status (Fried scale =>1 points)
- Cognitive impairment (Pfeiffer test)
- Severe concomitant disease that could hamper the participation in the study
- Patient refusal to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention on frailty 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
- Primary Outcome Measures
Name Time Method Change on frailty status according to the Fried scale 3 months and 1 year Points in the Fried scale
- Secondary Outcome Measures
Name Time Method All-cause mortality Up to 3 years Number of participants dead
Ischemic events (reinfarction or postdischarge revascularization) Up to 3 years Number of participants with reinfarction (readmission for chest pain with troponin elevation) or postdischarge revascularization (percutaneous coronary intervention or coronary surgery)
Change of Nutritional status (Mini Nutritional Assessment) 3 months and 1 year Mini Nutritional Assessment Test
Readmission for acute heart failure Up to 3 years Number of participants with readmission for acute heart failure
Readmission for non-cardiac causes Up to 3 years Number of participants with readmission for non-cardiac cause
Change of Quality of life (EUROQOL) 3 months and 1 year EUROQOL test
Change of Functional capacity (walk distance test) 3 months and 1 year Distance walked during 6 minutes
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 Up to 3 years Number of participants with the events
Trial Locations
- Locations (1)
Juan Sanchis
🇪🇸Valencia, Spain