Skip to main content
OpenTrials
Completed

NCT Number: NCT02715453

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Sanchis

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change on frailty status according to the Fried scale

    Time frame: 3 months and 1 year

    Points in the Fried scale

Secondary outcomes

  1. 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

    Time frame: Up to 3 years

    Number of participants with the events

  2. All-cause mortality

    Time frame: Up to 3 years

    Number of participants dead

  3. Ischemic events (reinfarction or postdischarge revascularization)

    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)

  4. Readmission for acute heart failure

    Time frame: Up to 3 years

    Number of participants with readmission for acute heart failure

  5. Readmission for non-cardiac causes

    Time frame: Up to 3 years

    Number of participants with readmission for non-cardiac cause

  6. Change of Quality of life (EUROQOL)

    Time frame: 3 months and 1 year

    EUROQOL test

  7. Change of Functional capacity (walk distance test)

    Time frame: 3 months and 1 year

    Distance walked during 6 minutes

  8. Change of Nutritional status (Mini Nutritional Assessment)

    Time frame: 3 months and 1 year

    Mini Nutritional Assessment Test

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Acronym: FRAMIP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 22, 2016
Registry last updated
Jan 22, 2021

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.

Published trials that share one or more normalized conditions with this study.