NCT00689416已完成早期 1 期
Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Comparison between the active and the placebo group regarding changes in MRI contrast enhancement in terms of the transfer constant (Ktrans) for the carotid region
研究概览
简要总结
The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these techniques are promising for future proof of principle studies. A number of patients will receive placebo as a control.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
- •Signed written Informed Consent.
- •Healthy men 18 - 70 years, women 60 - 70
排除标准
- •Use of a statin within six months before randomization.
- •Use of lipid altering medication other than statins within the last six months.
- •Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
- •Total cholesterol > 8, LDL-C > 6 or TG > 6 mmol/L at enrolment
研究组 & 干预措施
1
Experimental
干预措施: rosuvastatin (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Comparison between the active and the placebo group regarding changes in MRI contrast enhancement in terms of the transfer constant (Ktrans) for the carotid region
时间窗: MRI scan at enrolment visit and within group after 3 months.
次要结局
- Comparison between the active and the placebo group regarding changes in MRI contrast enhancement measured as fractional plasma volume (Vp) and changes in 18FDG uptake in terms of standardised uptake value (SUV), respectively(MRI scan at enrolment visit and within group after 3 months. 18FDG at randomisation visit (baseline) and within group after 3 months treatment.)
- Change in carotid MRI contrast enhancement in terms of Ktrans and Vp.(At enrolment visit and within group after 3 months treatment.)
- Change in 18FDG uptake in terms of SUV.(At randomisation visit (baseline) and within group after 3 months treatment.)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH)AtherosclerosisHyperlipidemiaNCT00885872Chinese PLA General Hospital60
已完成
3 期
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)Coronary ArteriosclerosisNCT00240318AstraZeneca450
已完成
3 期
Rosuvastatin Impact on Ventricular Remodelling Lipids and CytokinesHeart Failure, CongestiveNCT00240292AstraZeneca160
已完成
早期 1 期
Rosuvastatin (Crestor) in Friedreich AtaxiaFriedreich AtaxiaNCT02705547Children's Hospital of Philadelphia12
招募中
2 期
Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)Mild Cognitive ImpairmentNCT04765137Johns Hopkins University20