RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients (REBUS)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)|
- Death, myocardial infarction, stroke [ Time Frame: Five years from study start ] [ Designated as safety issue: Yes ]
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: 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 ] [ Designated as safety issue: Yes ]
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 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
Blood samples will be collected for analysis of biomarkers and platelets. At the first visit after the hospital stay blood for DNA analysis will also be collected.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital
|Contact: Christina Christersson, MD PhD||+46 (0)18 611 00 00 ext email@example.com|
|Contact: Bigitta Jönelid, MDfirstname.lastname@example.org|
|Uppsal University Hospital, 751 85 Uppsala, Sweden|
|Contact: Christina Christersson, MD PhD +46 (0)18 611 00 00 ext 90 68 email@example.com|
|Principal Investigator: Christina Christersson, MD PhD|
|Principal Investigator:||Christina Christersson, MD PhD||Cardiology Department, Uppsala University Hospital|