Registry of Bleeding Risk in Real World Chinese Acute Coronary Syndrome Patients-II
調査の概要
状態
詳細な説明
Acute coronary syndrome (ACS) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation.
With the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for ACS patients after PCI.Moreover,Bleeding after PCI therapy significantly increased short-term and long-term risk of death.
However, there is a lack of data on the risk of bleeding in ACS patients treated with PCI in the clinical reality world of china.
Therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
The present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in ACS patients undergoing PCI.
This study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in ACS patients undergoing PCI in China, and provide a reference for individual antithrombotic therapy after PCI.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Beijing、中国、100853
- 募集
- The General Hospital of PLA
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コンタクト：
- Yundai Chen, MD
- 電話番号：+8613311119778
- メール：cyundai@vip.163.com
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参加基準
適格基準
就学可能な年齢
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:
- age≥18 years, male or female;
- confirmed acute coronary syndrome patients;
- undergo percutaneous coronary intervention (PCI) treatment;
- agree to participate in this clinical study and sign a written consent form.
Exclusion Criteria:
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure;
- patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements;
- pregnant women or lactating women;
- investigators consider patients who were not suitable for participation with other reasons
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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Bleeding Risk in Chinese ACS II
1.This is an observational study，there is no intervention to be administered.
2.5500 ACS patients who meet the inclusion criteria for PCI treatment will be consecutively enrolled according to random number sampling.
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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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the incidence of major bleeding during each visit
時間枠：12 months
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Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard;
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12 months
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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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the incidence of major adverse cardiovascular events during each visit
時間枠：12 months
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Definition of major adverse cardiovascular events（MACE）：Cardiac death, nonfatal myocardial infarction, ischemic stroke, emergency revascularization;
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12 months
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協力者と研究者
捜査官
- 主任研究者：Yundai Chen, MD、The General Hospital of PLA
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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