search
Back to results

Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis (SMART-C)

Primary Purpose

Carotid Atherosclerosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Sonodynamic therapy (SDT)
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Atherosclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sonodynamic therapy(SDT)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in plaque FT volume, as assessed by MRI
The changes in plaque fibrous tissue(FT) volume as assessed by MRI.
Change in IPH volume, as assessed by MRI
The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
Change in calcification volume, as assessed by MRI
The changes in calcification volume as assessed by MRI.
Change in the status of fibrous cap, as assessed by MRI
The status of fibrous cap can be differentiated as thin/thick/ruptured assessed by MRI.
Change in plaque wall volume, as assessed by MRI
The changes in plaque wall volume(mm3) as assessed by MRI
Change in MVE, as assessed by CEUS
The changes in normalised maximal video-intensity enhancement (MVE) are calculated to quantify the density of IPN as assessed by CEUS.
Change in peak flow velocity, as assessed by doppler ultrasound
The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.
MACCE
incidence of major adverse cardiovascular and cerebrovascular events(MACCE)
Incidence of adverse events
Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Lipid change
To evaluate the change in lipid levels.

Full Information

First Posted
March 8, 2019
Last Updated
February 24, 2021
Sponsor
First Affiliated Hospital of Harbin Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03871725
Brief Title
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
Acronym
SMART-C
Official Title
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sonodynamic therapy(SDT)
Arm Type
Experimental
Arm Description
Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure.
Intervention Type
Combination Product
Intervention Name(s)
Sonodynamic therapy (SDT)
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Change in plaque LRNC volume, as assessed by MRI
Description
The changes in plaque lipid-rich necrotic core (LRNC) volume as assessed by MRI.
Time Frame
Measured at Baseline, 1, 3 months
Secondary Outcome Measure Information:
Title
Change in plaque FT volume, as assessed by MRI
Description
The changes in plaque fibrous tissue(FT) volume as assessed by MRI.
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in IPH volume, as assessed by MRI
Description
The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in calcification volume, as assessed by MRI
Description
The changes in calcification volume as assessed by MRI.
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in the status of fibrous cap, as assessed by MRI
Description
The status of fibrous cap can be differentiated as thin/thick/ruptured assessed by MRI.
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in plaque wall volume, as assessed by MRI
Description
The changes in plaque wall volume(mm3) as assessed by MRI
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in MVE, as assessed by CEUS
Description
The changes in normalised maximal video-intensity enhancement (MVE) are calculated to quantify the density of IPN as assessed by CEUS.
Time Frame
Measured at Baseline, 1, 3 months
Title
Change in peak flow velocity, as assessed by doppler ultrasound
Description
The changes of the systolic and diastolic peak flow velocity of the affected segments by doppler ultrasound.
Time Frame
Measured at Baseline, 1, 3 months
Title
MACCE
Description
incidence of major adverse cardiovascular and cerebrovascular events(MACCE)
Time Frame
Measured at Baseline, 1, 3 months
Title
Incidence of adverse events
Description
Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Time Frame
Measured at Baseline, 1, 3 months
Title
Lipid change
Description
To evaluate the change in lipid levels.
Time Frame
Measured at Baseline, 1, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YE TIAN
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis

We'll reach out to this number within 24 hrs