Clinical trial NCT02910687: FINE75+: 5 Year Follow up
Official title: Frailty as an INstrument for Evaluation of Elderly Patients With Non ST ElevationMyocardial Infarction (NSTEMI) - 5 Year Follow up (FINE75+5)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non ST Elevation Myocardial Infarction (NSTEMI)
Frailty
Keywords: Non ST Elevation Myocardial Infarction (NSTEMI)
Elderly
Frailty
Prognostic value
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-09-22
Enrollment: 307
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: All-cause mortality at 5 year follow up
timeFrame: 5 years
Secondary outcomes:
measure: Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.
timeFrame: 5 years
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: Linkoeping University Hospital
state: Ostergoetland
Study officials:
affiliation: Linkoeping University
name: Niklas Ekerstad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.