RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT01102933
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-22
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

1. 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.
2. Treated at the Department of cardiology, Uppsala University Hospital.
3. Ability to attend the scheduled visits for evaluation procedures.
4. Signed Informed Consent.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death, myocardial infarction, stroke	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 Outcome Measures

Name	Time	Method
Venous thromboembolism, Arterial embolism, Bleeding	Five years from study start	Venous thromboembolism: Deep venous thrombosis has to be diagnosed by ultrasonography or venography. Pulmonary embolism has to be diagnosed by spiral CT scan, pulmonary angiogram or ventilation-perfusion scanning.; Arterial embolism: Diagnosed as an arterial event. Radiological evidence includes imaging studies.; Bleedings: Classified as major or minor using International Society on Thrombosis and Haemostasis (ISTH). Major bleeds will be diagnosed as fatal and/or symptomatic bleeding in critical area or organ and/or bleeding associated with a decrease in Hb of 20 g/L or more or leading to transfusion.

Trial Locations

Locations (1)

Cardiology Department; 🇸🇪 Uppsal University Hospital, Uppsala, Sweden