Juan Sanchis
Valencia, 46010, Spain
NCT Number: NCT02715453
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.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multidisciplinary team (physicians, nurses, physiotherapists, and nutritionists):
Time frame: 3 months and 1 year
Points in the Fried scale
Time frame: Up to 3 years
Number of participants with the events
Time frame: Up to 3 years
Number of participants dead
Time frame: 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)
Time frame: Up to 3 years
Number of participants with readmission for acute heart failure
Time frame: Up to 3 years
Number of participants with readmission for non-cardiac cause
Time frame: 3 months and 1 year
EUROQOL test
Time frame: 3 months and 1 year
Distance walked during 6 minutes
Time frame: 3 months and 1 year
Mini Nutritional Assessment Test
University of Valencia
Other
Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
Acronym: FRAMIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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