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

Myocardial Infarction Clinical Trial

— REBUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102933
• Other study ID #: U-09-003
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: March 22, 2014
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2014
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Thromboembolism

Locations

Country	Name	City	State
Sweden	Cardiology Department	Uppsal University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, myocardial infarction, stroke	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.	Five years from study start	Yes
Secondary	Venous thromboembolism, Arterial embolism, Bleeding	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.	Five years from study start	Yes