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

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ClinicalTrials.gov Identifier: NCT02715453
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Juan Sanchis, University of Valencia

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.


Condition or disease Intervention/treatment Phase
Fragility Other: Intervention on frailty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
Study Start Date : January 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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
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

No Intervention: Control
Conventional strategy consisting only of the usual care by the cardiologist



Primary Outcome Measures :
  1. Change on frailty status according to the Fried scale [ Time Frame: 3 months and 1 year ]
    Points in the Fried scale


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715453


Locations
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Spain
Juan Sanchis
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Publications:
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Responsible Party: Juan Sanchis, Prof, University of Valencia
ClinicalTrials.gov Identifier: NCT02715453    
Other Study ID Numbers: 15/00837
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Juan Sanchis, University of Valencia:
Frailty
Acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Frailty
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases