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CompletedNCT02910687FINE75+5Updated Aug 11, 2017

FINE75+: 5 Year Follow up

An observational study in Non ST Elevation Myocardial Infarction (NSTEMI) and Frailty, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2017-08-11.

Sponsored by Linkoeping University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
307
Ages
75 Years and older
Sex
All
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Study summary

In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years old or older, were included between September 2009 and June 2010. The purpose of this observational study (FINE75+5) is to describe these patients, especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently associated with 5-year mortality.

Read the detailed description

The term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. Frailty stratification predicts a patient's risk of death and need for institutional care. The construct is well validated, but there is not one single accepted operational definition. The CSHA Clinical Frailty Scale (CFS) is a 7-point scale relying on clinical judgement. It is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.Though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with NSTEMI.

In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years old or older, were included between September 2009 and June 2010. We reported importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a NSTEMI population (Ekerstad et al. 2011, Ekerstad et al. 2013). However, there are no published data on the importance of frailty on longer-term outcome. Information on long-term prognosis may substantially improve informed decision making in elderly patients with NSTEMI, with acute potentially harmful treatments aiming at improved long-term prognosis.

The purpose of this study is to describe patients, 75 years old or older, with NSTEMI especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes.For the purpose of the current analysis all patients included in the final FINE 75+ study will be followed over 5 years from hospital admission. We hypothesize that frailty is independently associated with 5-year mortality.

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Conditions studied

  • Non ST Elevation Myocardial Infarction (NSTEMI)
  • Frailty

Keywords

  • Non ST Elevation Myocardial Infarction (NSTEMI)
  • Elderly
  • Frailty
  • Prognostic value
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 307 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients included in the FINE 75+ study population between October 2009 and June 2010. They were consecutive evaluable patients, 75 years old or older, with diagnosed NSTEMI,and cared for at one of the following hospital care units in the University Hospital ofLinköping and the County Hospitals in Trollhättan (NÄL-Uddevalla) and Jönköping (Ryhov): cardiology, acute medicine, geriatrics, other internal medicine unit.

Inclusion criteria

  • All patients included in the FINE 75+ study population between October 2009 and June 2010. Patients, 75 years old or older, with diagnosed NSTEMI, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit.

Exclusion criteria

Exclusion Criteria:

  • Not willing to participate. Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
307 participants (actual)
Patient registry
No

Groups and cohorts

  • NSTEMI75+

    Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)

    Other: This is an observational study

Interventions

  • OtherThis is an observational study
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What researchers measure

Primary outcomes

  1. All-cause mortality at 5 year follow up

    Time frame: 5 years

Secondary outcomes

  1. Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.

    Time frame: 5 years

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Study locations

1 site
  • Linkoeping University Hospital
    Linkoeping, Ostergoetland, Sweden
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References and documents

Publications

  • Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7. PubMed 22064593 ↗
  • Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Andersson D, Carlsson P. Frailty is independently associated with 1-year mortality for elderly patients with non-ST-segment elevation myocardial infarction. Eur J Prev Cardiol. 2014 Oct;21(10):1216-24. doi: 10.1177/2047487313490257. Epub 2013 May 3. PubMed 23644488 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02910687
Lead sponsor
Linkoeping University
Responsible party
Niklas Ekerstad (MD, PhD, Linkoeping University) — Principal investigator
First posted
Sep 22, 2016
Start date
Oct 2016
Primary completion
May 2017
Completion
Aug 2017
Last update
Aug 11, 2017

Study contacts

Niklas Ekerstad, MD, PhD
principal investigator · Linkoeping University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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