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

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Department

Uppsal University Hospital, Uppsala County, 751 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Treated at the Department of cardiology, Uppsala University Hospital.
Ability to attend the scheduled visits for evaluation procedures.
Signed Informed Consent.

Exclusion criteria

Death ≤ 5 days after the myocardial infarction.
Not belonging to the catchment area of Uppsala University Hospital.
Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: REBUS

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Apr 13, 2010
Registry last updated: Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed