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Trial record 58 of 93909 for:    5

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
Sponsor:
Information provided by (Responsible Party):
Niklas Ekerstad, Linkoeping University

Brief Summary:
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. The purpose of this observational study (FINE75+5) is to describe these patients, especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently associated with 5-year mortality.

Condition or disease Intervention/treatment
Non ST Elevation Myocardial Infarction (NSTEMI) Frailty Other: This is an observational study

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.

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.


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Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
NSTEMI75+
Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)
Other: This is an observational study



Primary Outcome Measures :
  1. All-cause mortality at 5 year follow up [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis. [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients included in the FINE 75+ study population between October 2009 and June 2010. They were 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 ofLinköping and the County Hospitals in Trollhättan (NÄL-Uddevalla) and Jönköping (Ryhov): cardiology, acute medicine, geriatrics, other internal medicine unit.
Criteria

Inclusion Criteria:

  • All patients included in the FINE 75+ study population between October 2009 and June 2010. 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.

Information from the National Library of Medicine

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


Locations
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Sweden
Linkoeping University Hospital
Linkoeping, Ostergoetland, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Niklas Ekerstad, MD, PhD Linkoeping University

Publications:
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Responsible Party: Niklas Ekerstad, MD, PhD, Linkoeping University
ClinicalTrials.gov Identifier: NCT02910687     History of Changes
Other Study ID Numbers: FINE75+5
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Niklas Ekerstad, Linkoeping University:
Non ST Elevation Myocardial Infarction (NSTEMI)
Elderly
Frailty
Prognostic value
Additional relevant MeSH terms:
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Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Frailty
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases