RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients (REBUS)
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Uppsala
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Uppsal University Hospital、Uppsala、スウェーデン、751 85
- Cardiology Department
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Unselected post-myocard infarct patients
Patients diagnosed with MI at Uppsala University Hospital
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Death, myocardial infarction, stroke
時間枠：Five years from study start
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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. |
Five years from study start
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Venous thromboembolism, Arterial embolism, Bleeding
時間枠：Five years from study start
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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. |
Five years from study start
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Christina Christersson, MD PhD、Cardiology Department, Uppsala University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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