NCT02910687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

September 20, 2016

Last Update Submit

August 9, 2017

Conditions

Non ST Elevation Myocardial Infarction (NSTEMI)Frailty

Keywords

Non ST Elevation Myocardial Infarction (NSTEMI)ElderlyFrailtyPrognostic value

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality at 5 year follow up

    5 years

Secondary Outcomes (1)

  • Rehospitalisation for myocardial infarction, stroke, other cardiovascular disease, bleeding complication, fracture, cancer or other diagnosis.

    5 years

Study Arms (1)

NSTEMI75+

Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)

Other: This is an observational study

Interventions

This is an observational studyOTHER
NSTEMI75+

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Not willing to participate. Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkoeping University Hospital

Linköping, Ostergoetland, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 22064593BACKGROUND

  • Ekerstad 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.

    PMID: 23644488BACKGROUND

MeSH Terms

Conditions

Non-ST Elevated Myocardial InfarctionFrailty

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Niklas Ekerstad, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)