Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Change in mean fibrous cap thickness measured by optical coherence tomography
研究概览
简要总结
Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time.
Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack.
Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA).
If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.
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
- 否
入选标准
- •Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
- •Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
- •Able to provide written informed consent.
排除标准
- •Cardiogenic shock requiring intubation, inotropes or a mechanical support device
- •Creatinine clearance <30ml/min
- •Prior coronary artery bypass grafting
- •Life expectancy less than 3 years
- •Pregnancy.
- •Target lesion in the left main coronary artery
- •Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
- •Chronic total occlusion of a major epicardial vessel.
研究组 & 干预措施
Standard of care
Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.
干预措施: Optical coherence tomography and pressure wire assessment (Diagnostic Test)
Standard of care
Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.
干预措施: Cardiac magnetic resonance angiogram (Diagnostic Test)
结局指标
主要结局
Change in mean fibrous cap thickness measured by optical coherence tomography
时间窗: 6 months
次要结局
- Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography(0 and 6 months)
- Change in mean lipid arc measured by optical coherence tomography(6 months)
- Presence of thin cap fibroatheroma measured by optical coherence tomography(6 months)