Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in plaque LRNC volume, as assessed by MRI
研究概览
简要总结
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The aim of this study is to assess the safety and efficacy of this technique.
详细描述
Carotid atherosclerotic plaque is an important cause of ischemic stroke, causes about 30% stroke/TIA attacks. Patients with carotid stenosis face an escalated risk of MI, PAD, and death. 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 aim of this trial is to assess the safety and efficacy of SDT. The SDT can induce macrophage elimination and inhibiting matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.
An estimated 80 eligible patients will be randomly divided into two groups: optimal medical care (OMC) combined with pseudo-SDT and OMC combined with SDT. Recruitment will be performed over 1 year and patients will be followed for 3 months; the anticipated total study duration will be 2 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 or during run-in
- •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
- •Not willing to be randomized into the 3 months trial
- •Patient who is attending other clinical trial
结局指标
主要结局
Change in plaque LRNC volume, as assessed by MRI
时间窗: Measured at Baseline, 1, 3 months
The changes in plaque lipid-rich necrotic core (LRNC) volume as assessed by MRI.
次要结局
- Change in the status of fibrous cap, as assessed by MRI(Measured at Baseline, 1, 3 months)
- Change in plaque burden, as assessed by MRI(Measured at Baseline, 1, 3 months)
- Change in calcification volume, as assessed by MRI(Measured at Baseline, 1, 3 months)
- MACCE(Measured at Baseline, 1, 3 months)
- Incidence of adverse events(Measured at Baseline, 1, 3 months)
- Lipid change(Measured at Baseline, 1, 3 months)
- Change in plaque FT volume, as assessed by MRI(Measured at Baseline, 1, 3 months)
- Change in IPH volume, as assessed by MRI(Measured at Baseline, 1, 3 months)
- Change in MVE, as assessed by CEUS(Measured at Baseline, 1, 3 months)
- Change in peak flow velocity, as assessed by doppler ultrasound(Measured at Baseline, 1, 3 months)
研究者
Ye Tian
Professor, MD, PhD
First Affiliated Hospital of Harbin Medical University