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

Fragility Clinical Trial

— FRAMIP  

Official title:

Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715453
• Other study ID #: 15/00837
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2020

Study information

• Verified date: January 2021
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fragility
• Frailty
• Infarction
• Myocardial Infarction

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Juan Sanchis	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Sanchis J, Bonanad C, Ruiz V, Fernández J, García-Blas S, Mainar L, Ventura S, Rodríguez-Borja E, Chorro FJ, Hermenegildo C, Bertomeu-González V, Núñez E, Núñez 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. — View Citation

Sanchis J, Núñez E, Ruiz V, Bonanad C, Fernández J, Cauli O, García-Blas S, Mainar L, Valero E, Rodríguez-Borja E, Chorro FJ, Hermenegildo C, Núñez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on frailty status according to the Fried scale	Points in the Fried scale	3 months and 1 year
Secondary	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	Number of participants with the events	Up to 3 years
Secondary	All-cause mortality	Number of participants dead	Up to 3 years
Secondary	Ischemic events (reinfarction or postdischarge revascularization)	Number of participants with reinfarction (readmission for chest pain with troponin elevation) or postdischarge revascularization (percutaneous coronary intervention or coronary surgery)	Up to 3 years
Secondary	Readmission for acute heart failure	Number of participants with readmission for acute heart failure	Up to 3 years
Secondary	Readmission for non-cardiac causes	Number of participants with readmission for non-cardiac cause	Up to 3 years
Secondary	Change of Quality of life (EUROQOL)	EUROQOL test	3 months and 1 year
Secondary	Change of Functional capacity (walk distance test)	Distance walked during 6 minutes	3 months and 1 year
Secondary	Change of Nutritional status (Mini Nutritional Assessment)	Mini Nutritional Assessment Test	3 months and 1 year