Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)

Frailty Clinical Trial

— FINE75+  

Official title:

Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049997
• Other study ID #: FINE75+
• Status: Completed
• Phase: N/A
• First received: January 14, 2010
• Last updated: March 30, 2015
• Start date: October 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2015
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

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. The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: March 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 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 (CFS).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Frailty
• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction (NSTEMI)

Locations

Country	Name	City	State
Sweden	The Center for Medical Technology Assessment/IMH, Linkoeping University	Linkoeping	Oestergoetland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Medical Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of death from any cause, myocardial infarction, revascularization due to ischemia, hospitalization from any cause, major bleeding, stroke/TIA and need for dialysis by one month after inclusion.		One month after inclusion	No
Secondary	The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.		One month after inclusion	No