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Clinical Trials/NCT01102933
NCT01102933
Completed
Not Applicable

RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)

Uppsala University1 site in 1 country425 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Uppsala University
Enrollment
425
Locations
1
Primary Endpoint
Death, myocardial infarction, stroke
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:

Evaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.

Evaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
August 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.
  • Treated at the Department of cardiology, Uppsala University Hospital.
  • Ability to attend the scheduled visits for evaluation procedures.
  • Signed Informed Consent.

Exclusion Criteria

  • Death ≤ 5 days after the myocardial infarction.
  • Not belonging to the catchment area of Uppsala University Hospital.
  • Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Outcomes

Primary Outcomes

Death, myocardial infarction, stroke

Time Frame: Five years from study start

Death: Death will be sub-classified by vascular or non-vascular primary cause. All deaths with unknown/uncertain cause will be categorized as vascular death. Myocardial Infarction(MI): Rehospitalization due to new non fatal MI or development of significant Q-wave. Stroke: Diagnosed as abrupt onset of focal neurological deficit persisting more than 24 hours.

Secondary Outcomes

  • Venous thromboembolism, Arterial embolism, Bleeding(Five years from study start)

Study Sites (1)

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