FINE75+: 5 Year Follow up (FINE75+5)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|