Carotid Atherosclerosis
Conditions
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.
Interventions
COMBINATION_PRODUCTSonodynamic therapy (SDT)
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%.
Sponsors
First Affiliated Hospital of Harbin Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plaque MaxWT, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | Measured at Baseline, 1, 3, 6, and 9 months | incidence of major adverse cardiovascular and cerebrovascular events(MACCE) |
| Incidence of adverse events | Measured at Baseline, 1, 3, 6, and 9 months | Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction |
| Change in IPH volume, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI. |
| Change in MVE, as assessed by CEUS | Measured at Baseline, 1, 3, 6, and 9 months | The changes in normalised maximal video-intensity enhancement (MVE) are calculated to quantify the density of IPN as assessed by CEUS. |
| Change in plaque LM volume, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in LM (loose matrix) volume as assessed by MRI. |
| Change in calcification volume, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in calcification (CA) volume as assessed by MRI. |
| Change in plaque volume, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in plaque volume(mm3) as assessed by MRI |
| Change in LRNC volume, as assessed by MRI | Measured at Baseline, 1, 3, 6, and 9 months | The changes in LRNC (lipid-rich necrotic core) volume as assessed by MRI. |
Countries
China
Outcome results
None listed