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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715453
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Juan Sanchis, University of Valencia

Tracking Information
First Submitted Date  ICMJE March 4, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE January 2016
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
Change on frailty status according to the Fried scale [ Time Frame: 3 months and 1 year ]
Points in the Fried scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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
  • All-cause mortality [ Time Frame: Up to 3 years ]
    Number of participants dead
  • 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)
  • Readmission for acute heart failure [ Time Frame: Up to 3 years ]
    Number of participants with readmission for acute heart failure
  • Readmission for non-cardiac causes [ Time Frame: Up to 3 years ]
    Number of participants with readmission for non-cardiac cause
  • Change of Quality of life (EUROQOL) [ Time Frame: 3 months and 1 year ]
    EUROQOL test
  • Change of Functional capacity (walk distance test) [ Time Frame: 3 months and 1 year ]
    Distance walked during 6 minutes
  • Change of Nutritional status (Mini Nutritional Assessment) [ Time Frame: 3 months and 1 year ]
    Mini Nutritional Assessment Test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction
Official Title  ICMJE Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fragility
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Intervention on frailty
  • No Intervention: Control
    Conventional strategy consisting only of the usual care by the cardiologist
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
150
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
200
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715453
Other Study ID Numbers  ICMJE 15/00837
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Juan Sanchis, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Valencia
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP