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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IPH volume, as assessed by MRI | The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI. | Measured at Baseline, 1, 3, 6, and 9 months |
| Change in LRNC volume, as assessed by MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YE TIAN | 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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|
The changes in LRNC (lipid-rich necrotic core) volume as assessed by MRI.
| Measured at Baseline, 1, 3, 6, and 9 months |
| Change in plaque LM volume, as assessed by MRI | The changes in LM (loose matrix) volume as assessed by MRI. | Measured at Baseline, 1, 3, 6, and 9 months |
| Change in calcification volume, as assessed by MRI | The changes in calcification (CA) volume as assessed by MRI. | Measured at Baseline, 1, 3, 6, and 9 months |
| Change in plaque volume, as assessed by MRI | The changes in plaque volume(mm3) as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 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, 6, and 9 months |
| MACCE | incidence of major adverse cardiovascular and cerebrovascular events(MACCE) | Measured at Baseline, 1, 3, 6, and 9 months |
| Incidence of adverse events | Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction | Measured at Baseline, 1, 3, 6, and 9 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |