RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients (REBUS)
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| First Received Date ICMJE | April 12, 2010 | ||||||||
| Last Updated Date | March 8, 2011 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01102933 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients | ||||||||
| Official Title ICMJE | RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected. |
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| Condition ICMJE | Myocardial Infarction | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 410 | ||||||||
| Estimated Completion Date | October 2016 | ||||||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01102933 | ||||||||
| Other Study ID Numbers ICMJE | U-09-003 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christina Christersson/MD PhD, Uppsala University Hospital | ||||||||
| Study Sponsor ICMJE | Uppsala University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Uppsala University | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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