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临床试验/NCT01443637
NCT01443637已完成不适用

COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry

Weill Medical College of Cornell University20 个研究点 分布在 7 个国家目标入组 34,000 人开始时间: 2003年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34,000
试验地点
20
主要终点
Coronary and non-coronary cardiac findings by CCTA

研究概览

简要总结

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.

详细描述

Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for prognostic risk assessment by CCTA findings but were limited by small patient cohorts or single centers. The CONFIRM Registry is a large, prospective, multinational dynamic observational study of patients undergoing CCTA. The primary aim of CONFIRM is to determine the prognostic value of CCTA findings for the prediction of future adverse CAD events.

The CONFIRM registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in North America, Europe, and Asia. CONFIRM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. Patients comprising the present CONFIRM cohort include those with suspected but without known CAD, with known CAD, or asymptomatic persons undergoing CAD evaluation. A data dictionary comprising a wide array of demographic, clinical, and CCTA findings was developed by the CONFIRM investigators and is uniformly used for all patients. Patients are followed up after CCTA performance to identify adverse CAD events, including death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
  • Interpretable CCTA
  • Prospective data collection for CAD risk factors.

排除标准

  • No explicit patient exclusion criteria are defined.

结局指标

主要结局

Coronary and non-coronary cardiac findings by CCTA

时间窗: yearly

Identify, quantify, and integrate coronary and noncoronary cardiac findings by Coronary computed tomographic angiography (CCTA) with demographic and clinical data for refinement of risk stratification of persons with suspected or known CAD.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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