Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in plaque MaxWT, as assessed by MRI
研究概览
简要总结
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose of this study is to evaluate the safety and initial effectiveness of this technique.
详细描述
Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial MR imaging of the carotid artery allowed observation of changes in plaque composition. Contrast enhanced ultrasound (CEUS) is a well accepted technique for detection of intraplaque neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage elimination and inhibit matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18- 80 years
- •Carotid artery with 30%~70% stenosis by ultrasound and plaque thickness>2.5mm
- •Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
- •Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP<140 and diastolic BP<90 under resting conditions) and diabetes(HbA1c<7%)
- •Written informed consent
排除标准
- •Non-atherosclerotic carotid artery stenosis
- •Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
- •Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit
- •Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
- •Previous significant adverse reaction to a statin
- •Systemic disorders such as hepatic, renal, hematologic, and malignant disease
- •Medical history that might limit the individual's ability to take trial treatments for the duration of the study
- •Allergic to DVDMS or sonovue
- •Diagnosis of porphyria
- •Pregnant women and nursing mothers
- •History of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy
- •Patient who is attending other clinical trial
结局指标
主要结局
Change in plaque MaxWT, as assessed by MRI
时间窗: Measured at Baseline, 1, 3, 6, and 9 months
The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI.
次要结局
- Incidence of adverse events(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in MVE, as assessed by CEUS(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in IPH volume, as assessed by MRI(Measured at Baseline, 1, 3, 6, and 9 months)
- MACCE(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in LRNC volume, as assessed by MRI(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in plaque LM volume, as assessed by MRI(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in calcification volume, as assessed by MRI(Measured at Baseline, 1, 3, 6, and 9 months)
- Change in plaque volume, as assessed by MRI(Measured at Baseline, 1, 3, 6, and 9 months)
研究者
Ye Tian
Professor, MD, PhD
First Affiliated Hospital of Harbin Medical University