Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis

NCT03871725 | Completed Phase 1

• 1 other identifier: SMART-C pilot
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in plaque MaxWT, as assessed by MRI

  The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI.

  Measured at Baseline, 1, 3, 6, and 9 months

Secondary Outcomes (8)

• Change in IPH volume, as assessed by MRI

  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

Study Arms (1)

Sonodynamic therapy(SDT)

EXPERIMENTAL

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

Combination Product: Sonodynamic therapy (SDT)

Interventions

Sonodynamic therapy (SDT) COMBINATION_PRODUCT

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%.

Sonodynamic therapy(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
• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

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

• YE TIAN

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: January 5, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (1)