FINE75+: 5 Year Follow up

Completed

• Conditions: Non ST Elevation Myocardial Infarction (NSTEMI); Frailty
• Interventions: Other: This is an observational study

• Registration Number: NCT02910687
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2016-10
• Status Verified: 2017-03
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSTEMI75+	This is an observational study	Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)

Primary Outcome Measures

Name	Time	Method
All-cause mortality at 5 year follow up	5 years

Secondary Outcome Measures

Name	Time	Method
Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.	5 years

Trial Locations

Locations (1)

Linkoeping University Hospital; 🇸🇪 Linkoeping, Ostergoetland, Sweden