Non ST Elevation Myocardial Infarction (NSTEMI)FINE75+NCT01049997
Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)
An observational study of Non ST Elevation Myocardial Infarction (NSTEMI) and Frailty, run by Linkoeping University at 1 site in Sweden.
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. 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
- How many people
- 307 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Mar 2012
- 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: 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.
Who may be able to join
- 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 (CFS).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Center for Medical Technology Assessment/IMH, Linkoeping University
Linköping, Östergötland County, 58183
About this study
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.
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. 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.
- Keywords
- Non ST Elevation Myocardial Infarction (NSTEMI), Elderly, Frailty
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI75+ | Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month after inclusion
Secondary outcomes (1)
The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.
Measured: One month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Niklas Ekerstad, Linkoeping University
- Investigators
- Niklas G Ekerstad, MD, Principal investigator, Linkoeping University, Sandbäcksgatan 7, 58183 Linkoeping, SwedenJoakim Alfredsson, PhD, Principal investigator, Department of Cardiology, University Hospital of Linkoeping, 58183 Linkoeping, SwedenMarcus Lindenberger, PhD, Principal investigator, Department of Cardiology, County Hospital Ryhov, 551 85 Joenkoeping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049997
- Sponsor's protocol ID
- FINE75+
- Acronym
- FINE75+
- Status last verified
- Mar 2015
- First submitted
- 14 Jan 2010
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. 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 Elevation Myocardial Infarction (NSTEMI)
- ClinicalTrials.gov ID
- NCT01049997
- Acronym / sponsor ID
- FINE75+ / FINE75+
- Keywords
- Non ST Elevation Myocardial Infarction (NSTEMI), Elderly, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Medical Research Council
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jan 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSTEMI75+ | – | –Patients, 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
- 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.
Key inclusion criteria (1 listed)
- 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 (2 listed)
- Not willing to participate.
- Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.
Time frame: One month after inclusion
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 31 Mar 2015.
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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 G Ekerstad, MD principal investigator
Linkoeping University, Sandbäcksgatan 7, 58183 Linkoeping, Sweden
Joakim Alfredsson, PhD principal investigator
Department of Cardiology, University Hospital of Linkoeping, 58183 Linkoeping, Sweden
Marcus Lindenberger, PhD principal investigator
Department of Cardiology, County Hospital Ryhov, 551 85 Joenkoeping, Sweden
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 2 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 31 Mar 2015. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.