Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques

Phase

1/2

Condition

Atherosclerosis

Carotid Artery Disease

Treatment

pseudo-SDT

Sonodynamic therapy (SDT)

Clinical Study ID

NCT03382249

Ye Tian carotid

Ages 18-80
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 6months
Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled bloodpressure(systolic BP<140 and diastolic BP<90 under resting conditions) anddiabetes(HbA1c<7%)
Written informed consent

Exclusion

Exclusion Criteria:

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 duringrun-in
Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis thatwould 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 forthe 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 carotidendarterectomy
Not willing to be randomized into the 3 months trial
Patient who is attending other clinical trial

Study Design

pseudo-SDT

1/2

September 20, 2023

Study Description

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.

Connect with a study center

The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150000
China
Site Not Available

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