RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients (REBUS)
|ClinicalTrials.gov Identifier: NCT01102933|
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : March 26, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||425 participants|
|Official Title:||RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)|
|Study Start Date :||April 2010|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital
- 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.
- Venous thromboembolism, Arterial embolism, Bleeding [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102933
|Uppsal University Hospital, Uppsala, Sweden, 751 85|
|Principal Investigator:||Christina Christersson, MD PhD||Cardiology Department, Uppsala University Hospital|