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

NCT03382249 | Withdrawn Phase 1

• 1 other identifier: Ye Tian carotid
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in plaque LRNC volume, as assessed by MRI

  The changes in plaque lipid-rich necrotic core (LRNC) volume as assessed by MRI.

  Measured at Baseline, 1, 3 months

Secondary Outcomes (10)

• 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 calcification volume, as assessed by MRI

  Measured at Baseline, 1, 3 months

• 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

Study Arms (2)

OMC and pseudo-SDT

PLACEBO COMPARATOR

Optimal medical care (OMC) and pseudo-SDT are administrated in this arm. OMC is established according to the standards established by the 2017 China Guidelines for the Diagnosis and Treatment of Carotid Artery Stenosis in order to promote best practices for risk factor management. Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.

Combination Product: pseudo-SDT

OMC and SDT

EXPERIMENTAL

OMC and sonodynamic therapy (SDT) are administrated in this arm.

Combination Product: Sonodynamic therapy (SDT)

Interventions

Sonodynamic therapy (SDT) COMBINATION_PRODUCT

Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%.

OMC and SDT

pseudo-SDT COMBINATION_PRODUCT

Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.

OMC and pseudo-SDT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead
• Tsinghua University: collaborator

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• TIAN YE

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 22, 2017
• Study Start: September 20, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)