OCT Plaque and Thrombus IMaging in Patients Who Underwent Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- Victar Hsieh
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evidence of plaque rupture by OCT imaging
研究概览
简要总结
Background
It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of the coronary artery, resulting in blood clots which impede blood flow. Currently, the investigators do not know whether heart attacks in patients who had a recent surgery are caused by the same disease process as those who did not have any surgery. This study will inform the investigators of very vital information about the cause of surgery-related heart attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT). Images will also be taken from heart attack patients who did not have recent surgery, and the two groups will be compared.
OCT imaging
OCT is a relatively new imaging technology which is much better at taking images of the inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary artery, it will record video images of a length of the artery. These images will take approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of the angiogram procedure is carried out in exactly the same way as it would normally proceed.
The OCT study will provide doctors with new information about the cause of surgery-related heart attacks, and will guide doctors in treating and preventing heart attacks in patients who undergo surgery.
Hypothesis
The investigators hypothesize that features of acute plaque rupture will be more common in patients with non-surgery related heart attacks compared to those which occur following surgery.
Design
Two groups of patients will be recruited(>20 in each group):
- non-surgery related heart attack patients
- patients who suffered from a heart attack following an operation.
Outcome measures
Using OCT, plaque features in coronary arteries of patients with heart attacks from both the surgical and non-surgical groups at the time of coronary angiogram will be compared.
详细描述
The majority of spontaneous non-ST segment elevation myocardial infarctions (NSTEMI) are attributed to rupture of an unstable atherosclerotic plaque in an epicardial coronary artery with thrombus formation. On the other hand, the pathophysiology underlying myocardial infarction following non-cardiac surgery is not well understood. The literature suggests that a significant proportion of myocardial infarctions following surgery may result from decreased myocardial perfusion in the presence of stable coronary artery disease without plaque rupture or thrombus formation.
Intra-coronary Optical Coherence Tomography (OCT) provides superior visualisation of the vascular lumen and structures close to the arterial lumen compared to IVUS, including features of plaque instability, including atherosclerotic plaque contents, fibrous cap thickness, thin cap fibroatheromas (TCFA), macrophage infiltration and calcium (2-10). OCT is therefore an ideal imaging technique to examine the pathophysiology involved in POMI, where features of plaque rupture and thrombus formation can be clearly distinguished from stable plaques.
An improved understanding of the pathophysiology of MI following non-cardiac surgery will guide management more appropriately.
Primary objective
- To identify features of acute plaque rupture in peri-operative myocardial infarction (POMI)
- To compare frequency of acute plaque rupture imaging findings between POMI and non-operative non-ST-elevation myocardial infarction (NSTEMI)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age over 18
- •Referred to coronary angiography with the view of revascularisation
排除标准
- •ST elevation myocardial infarction
- •Shock defined as the systolic blood pressure <90mmHg and tachycardia with heart rate >100 with evidence of systemic organ hypoperfusion.
- •Inability to give consent
- •Previous coronary artery bypass surgery due to the limited anticipated feasibility of OCT imaging in native vessels of patients with prior bypass grafts.
- •PCI with stenting in the previous 6 months due to the elevated risk of stent related complications (thrombosis or restenosis) as the potential cause of the NSTEMI.
- •GFR <35 due to need for additional 40-60 cc contrast during OCT imaging.
结局指标
主要结局
Evidence of plaque rupture by OCT imaging
时间窗: Day 1
OCT evidence of plaque rupture, presence of white or red thrombus will be collected at the time of coronary angiography.
次要结局
- Other features OCT features of atherosclerotic plaques.(Day 1)
研究者
Victar Hsieh
Interventional fellow
Hamilton Health Sciences Corporation