Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI) (FINE75+)
Recruitment status was Recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 14, 2010 | ||||||||||||
| Last Updated Date | February 9, 2011 | ||||||||||||
| Start Date ICMJE | October 2009 | ||||||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: One month after inclusion ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01049997 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion. [ Time Frame: One month after inclusion ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI) | ||||||||||||
| Official Title ICMJE | Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI) | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | NSTEMI75+
Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||||||
| Estimated Completion Date | June 2011 | ||||||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 75 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01049997 | ||||||||||||
| Other Study ID Numbers ICMJE | FINE75+ | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Professor Per Carlsson, Linkoeping University, Sandbäcksgatan 7,58183 Linkoeping, Sweden | ||||||||||||
| Study Sponsor ICMJE | Linkoeping University | ||||||||||||
| Collaborators ICMJE | Medical Research Council | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Linkoeping University | ||||||||||||
| Verification Date | February 2011 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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