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

NCT02715453 | Completed

• 1 other identifier: 15/00837
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fragility

Keywords

Frailty; Acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Change on frailty status according to the Fried scale

  Points in the Fried scale

  3 months and 1 year

Secondary Outcomes (8)

• 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

• All-cause mortality

  Up to 3 years

• Ischemic events (reinfarction or postdischarge revascularization)

  Up to 3 years

• Readmission for acute heart failure

  Up to 3 years

• Readmission for non-cardiac causes

  Up to 3 years

Study Arms (2)

Intervention on frailty

EXPERIMENTAL

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

Control

NO INTERVENTION

Conventional strategy consisting only of the usual care by the cardiologist

Interventions

Intervention on frailty OTHER

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

Intervention on frailty

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Admission for acute myocardial infarction and survivors in the hospitalization phase
• Age =\>70 years
• Prefrail or frail status (Fried scale =\>1 points)

You may not qualify if:

• Cognitive impairment (Pfeiffer test)
• Severe concomitant disease that could hamper the participation in the study
• Patient refusal to participate

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Juan Sanchis

Valencia, 46010, Spain

Location

Related Publications (3)

• 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.

  PMID: 26514748 BACKGROUND

• 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.

  PMID: 25440808 BACKGROUND

• 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.

  PMID: 33228950 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 22, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: February 1, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

ES (1)