OPTical Coherence Tomography IMAging in Patients With Acute myocardiaL Infarction During Primary PCI (OPTIMAL)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,500
- 试验地点
- 20
- 主要终点
- Major cardiovascular adverse events rate
研究概览
简要总结
The purpose of the study is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). About 4500 patients with acute myocardial infarction (estimated 1500 with OCT guidance and 3000 without OCT guidance during PCI）will be prospectively enrolled in 20 sites in China. The total duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for follow up.
详细描述
This is a prospective, multi-center, non-randomized, observational registry study of patients with acute myocardial infarction (AMI) that require catheterization. The purpose of this registry is to investigate the clinical outcomes, safety and cost-effectiveness of intravascular OCT imaging in patients with AMI undergoing PCI.The duration of the study is expected to be 5 years, 2 years for enrolment and 3 years for total follow up.The clinical study will be conducted in 20 centers in China.Approximately 4500 subjects (1500 with OCT imaging and 3000 without OCT imaging) will be enrolled in this study.Subjects will be followed up at 1, 3, 6, 12months and every 6 months afterwards up to 5 years. All subjects need to be followed for at least 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients presenting with:a.Symptoms of myocardial ischemia lasting for ≥ 30 minutes.b.Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads, or presumed new left bundle branch block. c. NSTEMI
- •Referred for primary PCI.
- •Are able to provide written Informed Consent prior to any study related procedure.
排除标准
- •Patient who is unable to comply with the follow-up schedule.
- •Left main occlusion
- •Unable to restore TIMI flow grade III before stenting
- •Prior coronary artery bypass surgery (CABG)
- •Cardiogenic shock
- •Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study.
- •Patient has a life expectancy of less than 6 month due to any condition.
- •Age ≤ 18 years
结局指标
主要结局
Major cardiovascular adverse events rate
时间窗: 1 year
In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding)
次要结局
- The incidence of procedural complications(baseline)
- The rate of procedural strategy changes during the primary PCI(baseline)
- Major cardiovascular adverse events rate(2 and 3 year)
- the indience of different plaque characteristic in the setting of STEMI(baseline)
研究者
Yu Bo
Director,Principal Investigator, Clinical Professor
Harbin Medical University