Status:
COMPLETED
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University
Conditions:
Carotid Atherosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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, hy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03871725
Start Date
January 5 2019
End Date
January 30 2020
Last Update
July 10 2024
Active Locations (1)
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1
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000