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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102933
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
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.

Condition or disease
Myocardial Infarction

Study Type : Observational
Actual Enrollment : 425 participants
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)
Study Start Date : April 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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
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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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102933

Cardiology Department
Uppsal University Hospital, Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
Principal Investigator: Christina Christersson, MD PhD Cardiology Department, Uppsala University Hospital

Responsible Party: Uppsala University Identifier: NCT01102933     History of Changes
Other Study ID Numbers: U-09-003
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis