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
  Purpose

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
Myocardial Infarction

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



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.


Enrollment: 425
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102933

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

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01102933     History of Changes
Other Study ID Numbers: U-09-003
Study First Received: April 12, 2010
Last Updated: March 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014