Fragility
Conditions
Keywords
Frailty, Acute myocardial infarction
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.
Interventions
OTHERIntervention 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
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on frailty status according to the Fried scale | 3 months and 1 year | Points in the Fried scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Readmission for acute heart failure | Up to 3 years | Number of participants with readmission for acute heart failure |
| 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 |
| 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 |
| Change of Nutritional status (Mini Nutritional Assessment) | 3 months and 1 year | Mini Nutritional Assessment Test |
| Readmission for non-cardiac causes | Up to 3 years | Number of participants with readmission for non-cardiac cause |
Countries
Spain
Outcome results
None listed