Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis

Phase 1

Completed

• Conditions: Carotid Atherosclerosis
• Interventions: Combination Product: Sonodynamic therapy (SDT)

• Registration Number: NCT03871725
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-01-05
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 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

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sonodynamic therapy(SDT)	Sonodynamic therapy (SDT)	Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.

Primary Outcome Measures

Name	Time	Method
Change in plaque MaxWT, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Measured at Baseline, 1, 3, 6, and 9 months	Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Change in MVE, as assessed by CEUS	Measured at Baseline, 1, 3, 6, and 9 months	The changes in normalised maximal video-intensity enhancement (MVE) are calculated to quantify the density of IPN as assessed by CEUS.
Change in IPH volume, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
MACCE	Measured at Baseline, 1, 3, 6, and 9 months	incidence of major adverse cardiovascular and cerebrovascular events(MACCE)
Change in LRNC volume, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in LRNC (lipid-rich necrotic core) volume as assessed by MRI.
Change in plaque LM volume, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in LM (loose matrix) volume as assessed by MRI.
Change in calcification volume, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in calcification (CA) volume as assessed by MRI.
Change in plaque volume, as assessed by MRI	Measured at Baseline, 1, 3, 6, and 9 months	The changes in plaque volume(mm3) as assessed by MRI

Trial Locations

Locations (1)

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China