Clinical trial NCT03382249: Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
Official title: Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Carotid Atherosclerosis
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Tsinghua University
First posted: 2017-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 or during run-in
* 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
* Not willing to be randomized into the 3 months trial
* Patient who is attending other clinical trial

Primary outcomes:
measure: Change in plaque LRNC volume, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
Secondary outcomes:
measure: Change in plaque FT volume, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in IPH volume, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in calcification volume, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in the status of fibrous cap, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in plaque burden, as assessed by MRI
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in MVE, as assessed by CEUS
timeFrame: Measured at Baseline, 1, 3 months
measure: Change in peak flow velocity, as assessed by doppler ultrasound
timeFrame: Measured at Baseline, 1, 3 months
measure: MACCE
timeFrame: Measured at Baseline, 1, 3 months
measure: Incidence of adverse events
timeFrame: Measured at Baseline, 1, 3 months
measure: Lipid change
timeFrame: Measured at Baseline, 1, 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: TIAN YE
role: STUDY_CHAIR
References: