Supplementation of Lycopene on Carotid Atheroma: Neovascularisation and Morphology (SOLANUM) Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Plaque morphology and biomechanics on magnetic resonance
研究概览
简要总结
Stroke is the second leading cause of death worldwide. One of the causes of stroke which can be treated is narrowing of the carotid artery. Currently the only definite treatment option is surgery or endovascular treatment. All patients not qualified for or awaiting surgery are, therefore, left with best medical therapy and with a yearly risk of stroke anywhere between 1% - 35% depending on the severity of the disease.
The study will use the properties of a tomato extract containing lycopene. Previously studies have demonstrated beneficial properties of tomato extracts:
- It decreases lipid oxidation
- It decreases DNA damage
- It has properties that reduce the speed and amount of cell divisions that inflammatory and smooth muscle cells undergo (both of these cell types contribute to atheroma formation).
The investigators wish to assess whether long-term food supplementation with a tomato extract containing lycopene could influence atherosclerotic plaque characteristics. The investigators will assess this using Magnetic Resonance Imaging of the plaque and transcranial Doppler ultrasonography for counting the number of blood clots that go to the brain's arteries. Furthermore the investigators wish to examine the effect of long-term food supplementation with a tomato extract containing lycopene on blood cholesterol levels and lipid oxidation and blood markers of inflammation and injury of the inner lining of the arteries.
This will be a single center, double blind, randomised, placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 - 90 years old,
- •Clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms:
- •Amaurosis fugax
- •Transient ischemic attack (TIA)
- •Stroke (ipsilaterally to the stenotic artery)
- •>30% stenosis on initial B-mode ultrasonography imaging,
- •Written, informed consent.
排除标准
- •Age <40 years old or >90 years old,
- •Time from symptom to recruitment > 2 months
- •<30% stenosis on B-mode ultrasonography imaging,
- •Scheduled for surgical/endovascular intervention within 3 months,
- •High-dose statin therapy (>80 mg/day fluvastatin; >40 mg/day simvastatin; >40 mg/day pravastatin; >10 mg/day atorvastatin; >10 mg/day rosuvastatin 21),
- •Other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements),
- •Chronic use of high dose aspirin >325 mg/day,
- •Allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin),
- •Contraindications for MRI studies including claustrophobia, any MRI non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.),
- •Known renal impairment with creatinine clearance <50 ml/min (as per departmental policy),
- •Women of childbearing potential,
- •Inability to consent
研究组 & 干预措施
Tomato extract (Ateronon)
Supplementation of tomato extract containing 28 mg/day for 12 months in addition to routine treatment.
干预措施: Ateronon (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Plaque morphology and biomechanics on magnetic resonance
时间窗: 12 months
Magnetic resonance imiging (MRI) of the plaques will be performed with detailed assessment of plaque morphological parameters: fibrous cap, lipid rich necrotic core, intraplaque hemorrhage. Sheer stress and wall stress will be calculated using magnetic resonance data.
Serum levels of lycopene - a component of the tomato extract
时间窗: 12 months
Serum levels of lycopene obtained through long-time supplementation with a tomato extract containing lycopene.
Microemboli on transcranial Doppler (TCD)
时间窗: 12 months
Amount of microeboli detected using bilateral middle cerebral artery (MCA) TCD monitoring (DWL, Germany, 2-MHz probe). TCD will be performed by a single investigator (KPB) for 1 hour
次要结局
- Biochemistry(12 months)
- Levels of blood circulating endothelial cells and endothelial progenitor cells(12 months)
- Plaque neovascularisation(12 months)
研究者
Karol Palwel Budohoski
Resident in Neurosurgery
Cambridge University Hospitals NHS Foundation Trust