FINE75+: 5 Year Follow up (FINE75+5)
|ClinicalTrials.gov Identifier: NCT02910687|
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment|
|Non ST Elevation Myocardial Infarction (NSTEMI) Frailty||Other: This is an observational study|
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 Type :||Observational|
|Actual Enrollment :||307 participants|
|Official Title:||Frailty as an INstrument for Evaluation of Elderly Patients With Non ST ElevationMyocardial Infarction (NSTEMI) - 5 Year Follow up (FINE75+5)|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||August 2017|
Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)
Other: This is an observational study
- All-cause mortality at 5 year follow up [ Time Frame: 5 years ]
- Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis. [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910687
|Linkoeping University Hospital|
|Linkoeping, Ostergoetland, Sweden|
|Principal Investigator:||Niklas Ekerstad, MD, PhD||Linkoeping University|