Carotid AtherosclerosisPhase 1/2SMART-CNCT03382249
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
A Phase 1/2 study testing Sonodynamic therapy (SDT) and pseudo-SDT in people with Carotid Atherosclerosis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Sonodynamic therapy (SDT) and pseudo-SDT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 20 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
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.
Read the detailed 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.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Sonodynamic therapy (SDT), pseudo-SDT
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%.
pseudo-SDTCombination product
Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: pseudo-SDT |
| OMC and SDT | Experimental | OMC and sonodynamic therapy (SDT) are administrated in this arm. Receives: Combination Product: Sonodynamic therapy (SDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque LRNC volume, as assessed by MRI
The changes in plaque lipid-rich necrotic core (LRNC) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3 months
Secondary outcomes (10)
Change in plaque FT volume, as assessed by MRI
The changes in plaque fibrous tissue(FT) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3 months
Change in IPH volume, as assessed by MRI
The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3 months
Change in calcification volume, as assessed by MRI
The changes in calcification volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3 months
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.
Measured: Measured at Baseline, 1, 3 months
Change in plaque burden, as assessed by MRI
The plaque burden including wall volume(mm3), vessel wall thicknesses(VWT)(mm) and percent wall volume(PWV)(%) .
Measured: Measured at Baseline, 1, 3 months
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.
Measured: Measured at Baseline, 1, 3 months
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.
Measured: Measured at Baseline, 1, 3 months
MACCE
incidence of major adverse cardiovascular and cerebrovascular events(MACCE)
Measured: Measured at Baseline, 1, 3 months
Incidence of adverse events
Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Measured: Measured at Baseline, 1, 3 months
Lipid change
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
Measured: Measured at Baseline, 1, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start20 Sep 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Why it stopped: redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Principal investigator, Ye Tian, First Affiliated Hospital of Harbin Medical University
- Investigators
- TIAN YE, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382249
- Sponsor's protocol ID
- Ye Tian carotid
- Acronym
- SMART-C
- Status last verified
- Sep 2023
- First submitted
- 4 Dec 2017
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
- ClinicalTrials.gov ID
- NCT03382249
- Acronym / sponsor ID
- SMART-C / Ye Tian carotid
- Conditions
- Carotid Atherosclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: redesign
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMC and pseudo-SDT | Placebo comparator | Combination Product: pseudo-SDTOptimal 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. |
| OMC and SDT | Experimental | Combination Product: Sonodynamic therapy (SDT)OMC and sonodynamic therapy (SDT) are administrated in this arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonodynamic therapy (SDT)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%. | Combination product | OMC and SDT |
| pseudo-SDTPseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression. | Combination product | OMC and pseudo-SDT |
Primary outcome
Change in plaque LRNC volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
The changes in plaque lipid-rich necrotic core (LRNC) volume as assessed by MRI.
10 secondary outcomes
Change in plaque FT volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
Change in IPH volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
Change in calcification volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
Change in the status of fibrous cap, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
Change in plaque burden, as assessed by MRI
Time frame: Measured at Baseline, 1, 3 months
Change in MVE, as assessed by CEUS
Time frame: Measured at Baseline, 1, 3 months
Change in peak flow velocity, as assessed by doppler ultrasound
Time frame: Measured at Baseline, 1, 3 months
MACCE
Time frame: Measured at Baseline, 1, 3 months
Incidence of adverse events
Time frame: Measured at Baseline, 1, 3 months
Lipid change
Time frame: Measured at Baseline, 1, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Related trials for Carotid Atherosclerosis
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
Not yet recruitingPhase 4
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Atherosclerosis Cerebral, Carotid Plaque
RecruitingObservational study
Photon-Counting CT Versus Conventional CT for Carotid Plaque Assessment in Patients With Carotid Artery Stenosis
Carotid Artery Stenosis, Carotid Atherosclerosis
Active, not recruitingPhase 2
SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPY
Atherosclerosis, Atheroscleroses, Coronary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TIAN YE study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sonodynamic therapy (SDT) and pseudo-SDT in people with Carotid Atherosclerosis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque LRNC volume, as assessed by MRI (time frame: Measured at Baseline, 1, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.