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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fragility

Intervention / Treatment
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* Other: Intervention on frailty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention on frailty<br>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 | Other: Intervention on frailty<br>* 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<br>|
| No Intervention: Control<br>Conventional strategy consisting only of the usual care by the cardiologist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on frailty status according to the Fried scale | Points in the Fried scale | 3 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of participants with the events | Up to 3 years | 
| All-cause mortality | Number of participants dead | Up to 3 years | 
| Ischemic events (reinfarction or postdischarge revascularization) | Number of participants with reinfarction (readmission for chest pain with troponin elevation) or postdischarge revascularization (percutaneous coronary intervention or coronary surgery) | Up to 3 years | 
| Readmission for acute heart failure | Number of participants with readmission for acute heart failure | Up to 3 years | 
| Readmission for non-cardiac causes | Number of participants with readmission for non-cardiac cause | Up to 3 years | 
| Change of Quality of life (EUROQOL) | EUROQOL test | 3 months and 1 year | 
| Change of Functional capacity (walk distance test) | Distance walked during 6 minutes | 3 months and 1 year | 
| Change of Nutritional status (Mini Nutritional Assessment) | Mini Nutritional Assessment Test | 3 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Acute myocardial infarction