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| Name | Class |
|---|---|
| Tsinghua University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| OMC and SDT | Experimental | OMC and sonodynamic therapy (SDT) are administrated in this arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plaque FT volume, as assessed by MRI | The changes in plaque fibrous tissue(FT) volume as assessed by MRI. | Measured at Baseline, 1, 3 months |
| Change in IPH volume, as assessed by MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TIAN YE | First Affiliated Hospital of Harbin Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| pseudo-SDT | Combination Product | Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression. |
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The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
| Measured at Baseline, 1, 3 months |
| Change in calcification volume, as assessed by MRI | The changes in calcification volume as assessed by MRI. | 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 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 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 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 at Baseline, 1, 3 months |
| MACCE | incidence of major adverse cardiovascular and cerebrovascular events(MACCE) | Measured at Baseline, 1, 3 months |
| Incidence of adverse events | Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction | 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 at Baseline, 1, 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |