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临床试验/NCT02347215
NCT02347215已完成不适用

Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年8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
212
试验地点
1
主要终点
Seattle Angina Questionnaire (SAQ) score

研究概览

简要总结

Serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.

详细描述

Some people with chest pain are found to have open arteries on angiograms instead of blocked arteries and many, but not all, of these people have abnormal stress tests or other tests showing there is not enough blood flow to the heart. Prior research has not made clear whether chest pain in such patients is due to heart disease or something else, in part because no one has found out whether chest pain and stress test results change in the same direction over time. This study will use two measurements of chest pain and two stress tests, one year apart, to find out if chest pain and abnormal stress tests are both caused by the same problem: not enough blood flow to the heart.The association between angina, ischemia and atherosclerosis severity at baseline will be examined, as will medication effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled but not randomized in ISCHEMIA trial
  • Stress echocardiography used for enrollment*
  • No obstructive CAD on study coronary CT angiography (defined as no ≥50% stenosis in a major epicardial vessel)
  • Ischemic symptoms (chest pain or other potential ischemic equivalent).
  • Participant is willing to give written informed consent
  • Age ≥ 21 years

排除标准

  • Inability to comply with protocol
  • Prior PCI or CABG

结局指标

主要结局

Seattle Angina Questionnaire (SAQ) score

时间窗: baseline-one year comparison

次要结局

  • Ischemia severity(baseline-one year comparison)
  • Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)(baseline)
  • Ischemia severity (comparison with SAQ score and with ischemia severity)(baseline)
  • Medical therapy used for angina (comparison with SAQ score and ischemia severity)(one year)
  • Major adverse cardiac events(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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