NCT02715453

Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction

Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fragility

Interventions

Type	Name	Description
OTHER	Intervention on frailty	Multidisciplinary team (physicians, nurses, physiotherapists, and nutritionists): * Nutritional evaluation and intervention after randomization and regularly during follow-up * Physiotherapy sessions for 3 months after randomization and home exercise program for 1 year * Psychiatrist or psychologist assistance for 1 year after discharge

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-08-01
• Completion: 2020-02-01
• First posted: 2016-03-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: Spain