Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis (NCT03871725) | Clinical Trial Compass
CompletedPhase 1
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
China12 participantsStarted 2019-01-05
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in plaque MaxWT, as assessed by MRI
Timeframe: Measured at Baseline, 1, 3, 6, and 9 months
Trial details
NCT IDNCT03871725
SponsorFirst Affiliated Hospital of Harbin Medical University