Non ST Elevation Myocardial Infarction (NSTEMI)FINE75+5NCT02910687
FINE75+: 5 Year Follow up
An observational study of Non ST Elevation Myocardial Infarction (NSTEMI) and Frailty, run by Linkoeping University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Non ST Elevation Myocardial Infarction (NSTEMI), Frailty
- What is being tested?
- This is an observational study
- How many people
- 307 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not willing to participate. Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty as an INstrument for Evaluation of Elderly Patients With Non ST ElevationMyocardial Infarction (NSTEMI) - 5 Year Follow up (FINE75+5)
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.
Read the 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.
- Being tested
- This is an observational study
- Keywords
- Non ST Elevation Myocardial Infarction (NSTEMI), Elderly, Frailty, Prognostic value
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI75+ | Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) Receives: Other: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 5 year follow up
Measured: 5 years
Secondary outcomes (1)
Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non ST Elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Niklas Ekerstad, Linkoeping University
- Investigators
- Niklas Ekerstad, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910687
- Sponsor's protocol ID
- FINE75+5
- Acronym
- FINE75+5
- Status last verified
- Mar 2017
- First submitted
- 20 Sep 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7.
PubMed 22064593Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Andersson D, Carlsson P. Frailty is independently associated with 1-year mortality for elderly patients with non-ST-segment elevation myocardial infarction. Eur J Prev Cardiol. 2014 Oct;21(10):1216-24. doi: 10.1177/2047487313490257. Epub 2013 May 3.
PubMed 23644488
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty as an INstrument for Evaluation of Elderly Patients With Non ST ElevationMyocardial Infarction (NSTEMI) - 5 Year Follow up (FINE75+5)
- ClinicalTrials.gov ID
- NCT02910687
- Acronym / sponsor ID
- FINE75+5 / FINE75+5
- Keywords
- Non ST Elevation Myocardial Infarction (NSTEMI), Elderly, Frailty, Prognostic value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSTEMI75+ | – | Other: This is an observational studyPatients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not willing to participate. Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study | Other | NSTEMI75+ |
Primary outcome
All-cause mortality at 5 year follow up
Time frame: 5 years
1 secondary outcome
Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 22064593Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7.
- Background: PubMed 23644488Ekerstad N, Swahn E, Janzon M, Alfredsson J, Lofmark R, Lindenberger M, Andersson D, Carlsson P. Frailty is independently associated with 1-year mortality for elderly patients with non-ST-segment elevation myocardial infarction. Eur J Prev Cardiol. 2014 Oct;21(10):1216-24. doi: 10.1177/2047487313490257. Epub 2013 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklas Ekerstad, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non ST Elevation Myocardial Infarction (NSTEMI) and Frailty, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 5 year follow up (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.