Clinical trial NCT02715453: Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction
Official title: Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragility
Keywords: Frailty
Acute myocardial infarction
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change on frailty status according to the Fried scale
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: 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
timeFrame: Up to 3 years
measure: All-cause mortality
timeFrame: Up to 3 years
measure: Ischemic events (reinfarction or postdischarge revascularization)
timeFrame: Up to 3 years
measure: Readmission for acute heart failure
timeFrame: Up to 3 years
measure: Readmission for non-cardiac causes
timeFrame: Up to 3 years
measure: Change of Quality of life (EUROQOL)
timeFrame: 3 months and 1 year
measure: Change of Functional capacity (walk distance test)
timeFrame: 3 months and 1 year
measure: Change of Nutritional status (Mini Nutritional Assessment)
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Juan Sanchis
Study officials:
References:
citation: Sanchis J, Nunez E, Ruiz V, Bonanad C, Fernandez J, Cauli O, Garcia-Blas S, Mainar L, Valero E, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Nunez J. Usefulness of Clinical Data and Biomarkers for the Identification of Frailty After Acute Coronary Syndromes. Can J Cardiol. 2015 Dec;31(12):1462-8. doi: 10.1016/j.cjca.2015.07.737. Epub 2015 Aug 21.
citation: Sanchis J, Bonanad C, Ruiz V, Fernandez J, Garcia-Blas S, Mainar L, Ventura S, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Bertomeu-Gonzalez V, Nunez E, Nunez J. Frailty and other geriatric conditions for risk stratification of older patients with acute coronary syndrome. Am Heart J. 2014 Nov;168(5):784-91. doi: 10.1016/j.ahj.2014.07.022. Epub 2014 Jul 30.
citation: Sanchis J, Sastre C, Ruescas A, Ruiz V, Valero E, Bonanad C, Garcia-Blas S, Fernandez-Cisnal A, Gonzalez J, Minana G, Nunez J. Randomized Comparison of Exercise Intervention Versus Usual Care in Older Adult Patients with Frailty After Acute Myocardial Infarction. Am J Med. 2021 Mar;134(3):383-390.e2. doi: 10.1016/j.amjmed.2020.09.019. Epub 2020 Oct 24.