NCT01049997

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.

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 2009

Typical duration 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

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

January 14, 2010

Last Update Submit

March 30, 2015

Conditions

Keywords

Non ST Elevation Myocardial Infarction (NSTEMI)ElderlyFrailty

Outcome Measures

Primary Outcomes (1)

  • 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.

    One month after inclusion

Secondary Outcomes (1)

  • The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.

    One month after inclusion

Study Arms (1)

NSTEMI75+

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

Eligibility Criteria

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

You may qualify if:

  • 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 (CFS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Medical Technology Assessment/IMH, Linkoeping University

Linköping, Östergötland County, 58183, Sweden

Location

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 G Ekerstad, MD

    Linkoeping University, Sandbäcksgatan 7, 58183 Linkoeping, Sweden

    PRINCIPAL INVESTIGATOR
  • Joakim Alfredsson, PhD

    Department of Cardiology, University Hospital of Linkoeping, 58183 Linkoeping, Sweden

    PRINCIPAL INVESTIGATOR
  • Marcus Lindenberger, PhD

    Department of Cardiology, County Hospital Ryhov, 551 85 Joenkoeping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

March 1, 2012

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations