Clinical trial NCT01049997: Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)
Official title: Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non ST Elevation Myocardial Infarction (NSTEMI)
Frailty
Keywords: Non ST Elevation Myocardial Infarction (NSTEMI)
Elderly
Frailty
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Medical Research Council
First posted: 2010-01-15
Enrollment: 307
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 of Linköping and the County Hospitals in Trollhättan (NÄL-Uddevalla) and Jönköping (Ryhov): cardiology, acute medicine, geriatrics, other internal medicine unit.

Brief 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.

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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: One month after inclusion
Secondary outcomes:
measure: The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.
timeFrame: One month after inclusion
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: The Center for Medical Technology Assessment/IMH, Linkoeping University
state: Oestergoetland
Study officials:
affiliation: Linkoeping University, Sandbäcksgatan 7, 58183 Linkoeping, Sweden
name: Niklas G Ekerstad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, University Hospital of Linkoeping, 58183 Linkoeping, Sweden
name: Joakim Alfredsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, County Hospital Ryhov, 551 85 Joenkoeping, Sweden
name: Marcus Lindenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: