China PEACE-Prospective 3-vessel Disease Study
The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Revascularization in Patients With Three-vessel Coronary Heart Disease
調査の概要
状態
条件
詳細な説明
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.
This study will enroll patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%) consecutively in 25 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect multiple vessel coronary heart disease patients recovery after PCI/CABG/medications, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Beijing
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Beijing、Beijing、中国、100037
- Fuwai Hospital
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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:
- Hospitalized patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%), using selective coronary angiography at index hospitalization.
Exclusion Criteria:
- Revascularization before the index admission
- Previously enrolled in the PEACE study
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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CABGグループ
初回入院時にCABGを受ける三枝病変患者
|
OMTグループ
初回入院時に血行再建術を受けていない三枝病変患者
|
PCI group
Three-vessel disease patients undergoing PCI at index hospitalization.
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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 |
---|---|---|
Major adverse cardiac events (MACE)
時間枠:1 year
|
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
|
1 year
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Symptoms status (SAQ)
時間枠:1 year
|
1 year
|
生活の質 (EQ-5D)
時間枠:1年
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1年
|
Coronary revascularization procedure
時間枠:1 year
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1 year
|
Re-admission
時間枠:1 year
|
1 year
|
Coronary death or myocardial infarction (fatal or non-fatal MI)
時間枠:1 year
|
1 year
|
Presumed ischemic stroke (i.e. not known to be hemorrhagic)
時間枠:1 year
|
1 year
|
Death from all cardiovascular causes
時間枠:1 year
|
1 year
|
Status of general health (SF-12)
時間枠:1 year
|
1 year
|
協力者と研究者
捜査官
- 主任研究者:Lixin Jiang, M.D., Ph.D.、China National Center for Cardiovascular Diseases
- 主任研究者:Harlan M Krumholz, M.D., S.M.、Yale University
出版物と役立つリンク
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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