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临床试验/NCT02776657
NCT02776657已完成不适用

Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.

University of Edinburgh0 个研究点目标入组 40 人开始时间: 2016年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.

研究概览

简要总结

This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood clots can be identified within the blood vessels supplying blood to the heart in patients with angina and who have recently suffered a heart attack.

详细描述

The majority of heart attacks are caused as a result of small blood clots forming within the blood vessels supplying blood to the heart, obstructing blood flow to the heart muscle. Research has also shown that blood clots may form in the blood vessels of the heart without causing a heart attack. At present, blood clots may be identified by techniques used during invasive coronary angiography, but we wish to determine whether a non-invasive test (MRI scanning) can be used to detect small blood clots within the blood vessels supplying blood to the heart muscle.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Aged over 18 years
  • Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR
  • Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria;
  • Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).
  • Symptoms of myocardial ischaemia
  • Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2)
  • Planned invasive coronary angiography

排除标准

  • Contraindication or inability to undergo MRI scanning
  • Renal failure (estimated glomerular filtration rate less than 30millilitres/minute)
  • Undergoing Primary Percutaneous Coronary Intervention
  • Ongoing myocardial ischaemia or dynamic ECG changes
  • Inability to provide informed consent
  • Known allergy to gadolinium based contrast
  • Women who are pregnant, breastfeeding or of child-bearing potential

结局指标

主要结局

Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.

时间窗: Within 72 hours prior to angiography

次要结局

  • The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).(Through study completion, an average of 1 year)
  • The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).(Baseline and 3 months)
  • Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.(Through study completion, an average of 1 year)
  • The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).(Baseline and 1 month)

研究者

申办方类型
Other
责任方
Sponsor

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