Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- myocardial salvage (17 segment model) by SPECT
研究概览
简要总结
The objectives of this study are to observe and examine prospectively whether excimer laser coronary angioplasty (ELCA) and percutaneous coronary intervention with biodegradable-polymer platinum chromium everolimus-eluting stent may improve the myocardial salvage in the patients with anterior ST elevation myocardial infarction (STEMI) using the myocardial scintigram (acute-phase I123-BMIPP and chronic-phase 99mTc-tetrofosmin), and to clarify the myocardial protective effect of excimer laser in the patients with anterior STEMI.
详细描述
The clinical result of catheter treatment in the patients with acute myocardial infarction in these several decades improved because of progress of early reperfusion therapy and stent treatment technique. However, the no-reflow phenomenon is still remaining as a problem, which is involved in a decrease in left ventricular function and worsening of prognosis. It is considered that the no-reflow phenomenon is induced by atherosclerotic and thrombotic emboli, endothelial dysfunction of capillary vessels, free radicals and cytokine. The treatment combining the peripheral protection and thrombus aspiration aiming at prevention of no-reflow is expected to reduce no-reflow and the infarct size and has been conducted on the patients with acute myocardial infarction. However, a lot of randomized studies have been conducted, so far, which do not lead to reduction of infarct size and improvement of survival rate, and the efficacy has not been demonstrated.
Some explanations have been suggested for this phenomenon:
- The operation method of device is complicated, and it is difficult to acquire the treatment technique.
- Giant thrombus and solid lesion could not be aspirated effectively.
- A lot of randomized studies have not focused on the "patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours," considered to have the largest benefit of prevention of no-reflow.
In recent years in Japan, excimer laser coronary angioplasty (ELCA) has been used in the patients with acute coronary syndrome (ACS), and not only debulking of arteriosclerotic lesion but also thrombolytic effect have been reported. In the Camel trial and Utility of Laser for Transcatheter Atherectomy Multicenter Analysis around Naniwa (ULTRAMAN) registry, the efficacy and safety in ACS have been reported, but the infarct size has not been evaluated.
This time in this study, it is considered that verification whether or not ELCA is able to improve the myocardial salvage in anterior ST elevation myocardial infarction (STEMI) using myocardial scintigram (acute-phase BMIPP and chronic-phase TF) will provide the useful information helpful for selection of treatment to medical care staffs and patients for future patients suffering from ACS and will be able to contribute to further improvement of medical science and medical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open -but assessors are blinded
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to whom PCI treatment for anterior STEMI is indicated [Main selection criteria]
- •First-episode anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria
- •Patients who are 21 years of age or older at the time of consent acquisition
- •Patient who the patient himself agreed in writing
排除标准
- •Patients presenting cardiac shock at the time of visit
- •Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch
- •Patients who have TIMI 2, 3 at the initial imaging
- •Patients with a reference vessel diameter of 2.5 mm or less
- •Patients determined to lack consent ability for mental or other reasons
- •Patient who is judged inappropriate by research researcher or research sharing doctor
- •The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions.
- •Atrial fibrillation subject at the timing of MRI scan
- •Internally implanted devices such as pacemakers or ICDs
- •Subject that is allergic to Gadolinium,
- •Subject with claustrophobia
- •Pregnancy
结局指标
主要结局
myocardial salvage (17 segment model) by SPECT
时间窗: 3 day to 6 month
Calculation of score using software in the Core Lab (Tokai University, Department of Radiology). Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images. The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ( ∑123I-BMIPP defect score minus 99mTc-∑tetrofosmin defect score).
Myocardial Salvage index (17 segment model) by SPECT
时间窗: 3 day to 6 month
Salvage index was calculated as follows: Myocardial Salvage index =∑123I-BMIPP defect score minus ∑99mTc-tetrofosmin defect score/ ∑123I-BMIPP defect score × 100 (%).
次要结局
- Myocardial salvage assessment by MRI(5-9 days and 6 month)
- Ejection fraction assessment by MRI(5-9 days and 6 month)
- Myocardial salvage [total perfusion defect (TPD) model] by SPECT(3 day to 6 month)
- Microvascular obstruction assessment by MRI(5-9 days and 6 month)
- Gray zone assessment by MRI(5-9 days and 6 month)
- Left ventricular ejection fraction by TF scintigraphy at 6 months(5-7 month)
- Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT(3 day to 6 month)
- Myocardial scar amount assessment by MRI(5-9 days and 6 month)
- Left ventricular volume (ml) by TF scintigraphy at 6 months(5-7 month)
- Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months(5-7 month)
- Major adverse cardiovascular events (MACE) at 36 months(36 months)
- Intra-stent tissue volume by OCT(at the end of procedure and 1-year)
- Major adverse cardiovascular events (MACE) at 12 months(12 months)
- Cardiac death at 12 months(12 months)
- Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months(5-7 month)
- Cardiac death at 36 months(36 months)
- Cardiac death at 60 months(60 months)
- Major adverse cardiovascular events (MACE) at 60 months(60 months)