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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01102933
First received: April 12, 2010
Last updated: March 22, 2014
Last verified: March 2014

April 12, 2010
March 22, 2014
April 2010
August 2012   (final data collection date for primary outcome measure)
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(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.

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.

Complete list of historical versions of study NCT01102933 on ClinicalTrials.gov Archive Site
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 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.

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.

Not Provided
Not Provided
 
RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients
RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.

Myocardial Infarction
Not Provided
Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01102933
U-09-003
No
Uppsala University
Uppsala University
Not Provided
Principal Investigator: Christina Christersson, MD PhD Cardiology Department, Uppsala University Hospital
Uppsala University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP