Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction
NCT ID: NCT02715453
Last Updated: 2021-01-22
Study Results
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Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2016-01-31
2020-02-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention on frailty
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
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
Control
Conventional strategy consisting only of the usual care by the cardiologist
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Age =\>70 years
* Prefrail or frail status (Fried scale =\>1 points)
Exclusion Criteria
* Severe concomitant disease that could hamper the participation in the study
* Patient refusal to participate
70 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Juan Sanchis
Prof
Locations
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Juan Sanchis
Valencia, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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15/00837
Identifier Type: -
Identifier Source: org_study_id
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