OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Stent endometrial coverage measured by OCT
研究概览
简要总结
This is a prospective study of a new generation of drug-eluting stent in the treatment of non ST elevation acute coronary syndrome (NSTE-ACS). The purpose of this study was to evaluate the extent of early vascular repair in NSTE-ACS patients after receiving the new generation of drug-eluting stents, and the value of OCT guided optimal implantation in further improving the target vascular endothelial repair, so as to provide the basis for early discontinuation of dual antiplatelet drugs (dapt) in NSTE-ACS patients and later large-scale randomized clinical research.This study is a prospective, multicenter, randomized controlled clinical study. Sixty patients with non ST elevation acute coronary syndrome (NSTE-ACS), including unstable angina and acute non ST elevation myocardial infarction, were enrolled in this study. After obtaining the written consent of the patients, the computer-generated random sequence table was randomly divided into three-month follow-up group (O3 group, n = 20), three-month follow-up group (A3 group, n = 20) and six-month follow-up group (A6 group, n = 20). Among them, the OCT guidance group needs to optimize the operation according to the examination results before and after the operation, while the contrast guidance group only conducts OCT examination collection after the operation. During the study period, all patients were given dual antiplatelet therapy (aspirin 100mg / D, clopidogrel 75mg QD or tegrilol 90mg bid). Sixty patients were followed up at 30 days, 3 months, 6 months and 1 year after stent implantation, and OCT was performed at 3 or 6 months after stent implantation, with the coverage rate of neointima as the main observation index. In this experiment, the independent OCT imaging laboratory, data management and Statistics Center, clinical endpoint determination Committee and clinical supervision organization collected, sorted, statistically analyzed and determined all relevant clinical and OCT imaging data. All the selected patients were followed up continuously within one year (telephone or outpatient follow-up) to observe the occurrence of adverse events.Primary end point: stent endometrial coverage measured by OCT (%)。
详细描述
This study is a prospective, randomized controlled clinical trial, which will adopt the central randomized method based on computer system. When a patient signs the informed consent form and meets the inclusion criteria of the trial, and there is no exclusion criteria for randomization, the researcher fills in the randomization application form, and carries out randomization by landing on the randomization website randomization system. The computer system will automatically assign the randomization number and the corresponding treatment group according to the patient's situation. After obtaining the randomization results, the researcher should be in the randomization application form and the original The random number was recorded on the case and the patients were treated according to the group (Trial / control) assigned by the system.
The trial was carried out according to the following procedures: (1) signing informed consent; (2) case screening; (3) case selection; (4) The baseline OCT imaging was completed in the O3 group (including preoperative, intraoperative and postoperative use), and only OCT examination was performed in the A3 and A6 groups (not used to guide the optimization of PCI operation); (5) Follow up evaluation: ① OCT follow-up was conducted 3 or 6 months after the operation, and the imaging results were sent to the medical imaging analysis department for qualitative and quantitative evaluation and analysis; ② outpatient or telephone follow-up was conducted 1, 3, 6 and 12 months after the operation, and cardiovascular clinical events were recorded; The results of optical coherence tomography (OCT) in this study were evaluated by medical imaging analysis department. According to the standard procedure, the results of OCT imaging after stent implantation, 3 or 6 months after operation and any unexpected results are sent to the medical imaging analysis department, and the qualitative and quantitative evaluation analysis are completed by experienced image analysts. When the medical imaging analysis department evaluates the imaging results, it does not know whether the patients come from the experimental group or the control group, that is, they are always in a blind state. All calculation results were unblinded at the same time when the main end point data of the test were completed.
The task of data management and statistical analysis of this experiment will be undertaken by clinical research center of cardiovascular medicine of the third people's Hospital of Xuzhou City, and the statistical professionals will participate in the whole process of research design, implementation, data management and analysis and summary of test results. After the completion of the study plan and case report form, a statistical analysis plan will be made to complete the statistical analysis report.
The case report form (CRF) is filled in by the investigator, and each selected case must complete the CRF. After the completed case report form is reviewed by the supervisor, the first copy is transferred to the data administrator for data entry and management. After the first copy is handed over, the contents of the case report form will not be modified. The data administrator uses software to compile data entry program for data entry and management. In order to ensure the accuracy of the data, two data entry personnel shall independently enter and proofread the data in duplicate. For the questions in the case report form, the data administrator will send a query to the researcher by generating a question answer form (QF, query form), and contact the researcher through the supervisor to answer and return as soon as possible; the data administrator will modify, confirm and input the data according to the researcher's answers, and can send a QF again if necessary. After the data is reviewed and confirmed to be correct, the data management personnel, main researchers, statistical analysts, implementers and audit management personnel shall jointly review the data, and complete the final definition and judgment of the analysis population, and then the data administrator shall lock the database. Generally, the locked database or file cannot be changed. After the database is locked, submit it to the statistical analyst for statistical analysis.
During the clinical trial, the investigator of the hospital where the implementer is located and the investigator of the third people's Hospital of Xuzhou City will visit the research center regularly to ensure that all contents of the research scheme are strictly observed, and the original data are checked to ensure that the content of CRF is true, complete and correct.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non pregnant female aged 18-80;
- •Patients with unstable angina or acute non ST segment elevation myocardial infarction have been diagnosed clinically;
- •The target lesions are primary and in situ coronary lesions. If there are multiple target lesions, they must be located in different epicardial vessels;
- •The total length of each target lesion is ≤ 40mm, and the diameter of the target vessel is 2.5mm-4.5mm (visual method);
- •The stenosis degree of target lesion ≥ 70% or the stenosis degree of target lesion with evidence of myocardial ischemia ≥ 50% (visual method);
- •Each patient is allowed to implant at most 3 homostents (except for salvage implantation of additional stents), and each target lesion is allowed to implant at most 2 homostents;
- •Patients with indication of coronary artery bypass surgery;
- •Patients who can understand the purpose of this trial, voluntarily participate in and sign the informed consent, have good compliance after discharge, take medicine on time, and are willing to receive optical coherence tomography (OCT) examination and clinical follow-up.
排除标准
- •Any acute ST segment elevation myocardial infarction within 1 month;
- •Chronic total occlusion (preoperative Timi Grade 0 blood flow), severe left main coronary artery disease, long disease (disease length > 40mm), bifurcated disease with double stenting, diameter of disease vessel > 4.5mm, incomplete optical coherence tomography (OCT) at the lesion site or the disease is not suitable for OCT imaging, bypass vessel disease, visible thrombus in the target vessel, concurrent infection or other inflammatory diseases;
- •Severe calcification and tortuosity can not be successfully pre dilated, which is not suitable for stent delivery and expansion;
- •Restenosis in stent;
- •Patients who had implanted any brand of stent in one year, those who had the possibility of reoperation in one year, and those who had implanted stent for more than one year;
- •Hemodynamics or respiratory and circulatory instability have been demonstrated, such as cardiogenic shock, severe heart failure (NYHA III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventriculography);
- •The renal function was damaged before operation: EGFR < 60ml / (min · 1.73m2) or serum creatinine > 2.5mg/dl (178 μ mol / L);
- •Patients with bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or subretinal hemorrhage, history of stroke within half a year, contraindications of antiplatelet agents and anticoagulants cannot receive anticoagulant treatment;
- •Allergic to aspirin, clopidogrel or tegrelol, statins, heparin, contrast agents, polymers, zoltamox and metals;
- •The life expectancy of patients is less than 12 months;
- •Those who have participated in clinical trials of other drugs or medical devices before being selected but failed to reach the time limit of main research end point;
- •The researcher judges that the patient's compliance is poor and is unable to complete the study as required, unwilling or unable to provide written informed consent;
- •Heart transplant patients;
- •There are unstable arrhythmias, such as high-risk ventricular premature beats and ventricular tachycardia;
- •Because the tumor needs chemotherapy within 30 days;
- •Have immunosuppressive, autoimmune diseases, plan or are receiving immunosuppressive treatment;
- •Patients who need to stop aspirin, clopidogrel or tegrilol due to selective surgery within half a year;
- •Blood routine examination showed that platelet count was lower than 100 × 10∧9/ L, or higher than 700 × 10∧9 / L, leukocyte was lower than 3 × 10∧9 / L, and liver diseases (such as hepatitis) were diagnosed or suspected;
- •The patient had diffuse peripheral vascular disease and could not use 6F catheter.
结局指标
主要结局
Stent endometrial coverage measured by OCT
时间窗: 3 to 6 months after operation
Patients were randomly assigned to the 3-month or 6-month follow-up group。According to the randomized group, Oct reexamination was carried out at 3 or 6 months after the operation to evaluate the stent endometrial coverage rate。
次要结局
- All revascularization(30 days, 3 months, 6 months and 1 year after operation)
- Nonfatal myocardial infarction(30 days, 3 months, 6 months and 1 year after operation)
- Covering thickness of scaffold surface structure(3 to 6 months after operation)
- Vascular repair index(3 to 6 months after operation)
- cardiovascular death(30 days, 3 months, 6 months and 1 year after operation)
- Target vessel revascularization(30 days, 3 months, 6 months and 1 year after operation)
- minimum and average lumen area, the minimum stent area and the average stent area(3 to 6 months after operation)
- Poor adherence rate of stent wire during follow-up(3 to 6 months after operation)
- Minimum stent diameter and average stentdiameter,minimum lumen diameter and average lumen diameter(3 to 6 months after operation)
- Target lesion revascularization(30 days, 3 months, 6 months and 1 year after operation)
- Stent thrombosis(30 days, 3 months, 6 months and 1 year after operation)