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临床试验/NCT01833338
NCT01833338终止不适用

Coronary Artery Plaque Characterisation With Non-invasive Multi-Slice Computed Tomography and Invasive Intravascular Ultrasound and Optical Coherence Tomography in Patients With Acute Coronary Syndromes Without ST-segment Elevation

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.

研究概览

简要总结

The accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.

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

入选标准

  • Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads); - Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.

排除标准

  • Persistent ST-elevation of >1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) < 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.

研究组 & 干预措施

Single arm

Other

There is only one arm in this study. All patients undergo MSCT, IVUS and OCT.

干预措施: Imaging (Device)

结局指标

主要结局

Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.

时间窗: 24 hours

All imaging methods will be performed in each patient. A 24 hour period is the maximum allowed time gap between MSCT and invasive imaging (OCT/IVUS).

次要结局

  • Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabija Pundziute

Principal Investigator

University Medical Center Groningen

研究点 (2)

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