日本冠状动脉疾病(JCAD)研究的设计和基本原理:一项大规模、多中心前瞻性队列研究。

Doubun Hayashi, Tsutomu Yamazaki
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引用次数: 18

摘要

由于日本的冠状动脉疾病患者证据不足,日本冠状动脉疾病(JCAD)研究旨在收集基于循证医学(EBM)的基本数据,有217家机构参与。在本研究中,所有病例均行心导管术,根据AHA分类,至少有一个冠状动脉分支狭窄达到75%或以上的标准,选择确诊为CAD的研究对象。数据包括背景信息、风险因素、临床管理和药物将通过网络收集。本研究的随访组包括对每个受试者进行为期3年的随访,以获得CAD患者的长期预后数据;另一组为每6个月招募新受试者,随访6个月,仅用于确定患者的最新趋势。这项研究的两部分自2000年4月以来一直在进行。截至2003年9月30日,随访组共入组15506名受试者,随访数据已录入数据库。作者计划报道在日本有史以来最大的心导管确诊冠状动脉病变患者队列研究中获得的数据,显示发生率(主要集中在脑血管事件)与其他因素(如危险因素的管理)、药物类型和剂量之间的相关性。
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Design and rationale of the Japanese Coronary Artery Disease (JCAD) Study: a large-scale, multicentered prospective cohort study.
Since there is in sufficient evidence on patients with coronary artery disease in Japan, the Japanese Coronary Artery Disease (JCAD) Study, in which 217 institutions participate, was designed to collect basic data based on evidence-based medicine (EBM). In this study, cardiac catheterization is performed on all cases to select study subjects confirmed as having CAD diagnosed based on the criteria that he or she has stenosis in at least one branch of a coronary artery to the extent of 75% or higher according to the AHA classification. Data including background information, risk factors, clinical management, and medication are to be collected over the web. The follow-up arm of the study consists of following each subject for three years to obtain data on the long-term prognosis of patients with CAD while the other arm is for enrolling new subjects every six months who will be followed for six months only for the purpose of determining the latest trend in patients. The two arms of the study have been ongoing since April 2000. As of September 30, 2003, 15,506 subjects have been enrolled in the follow-up arm and the follow-up data have been entered in the database. The authors plan to report data showing any correlation between incidence rate, focusing mainly on cerebrocardiovascular events, and other factors such as the management of risk factors, and type and dosage of medications obtained in the largest cohort ever studied in Japan of patients with a coronary artery lesion confirmed by cardiac catheterization.
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