NL-OMON47981尚未招募不适用
Effects of vitamin K2 supplementation on [18]F-NaF PET/MRI in patients with carotid and coronary artery disease - INTRICATE
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 52 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* * Asymptomatic carotid artery disease on at least one side with a degree of
- •stenosis > 25% (according to on the ECST criteria). If the patient has a
- •symptomatic carotid artery disease on the contra-lateral side, he/she will
- •still be included in the study., iIf intensified medical treatment for this
- •symptomatic stenosis (e.g. statins, antiplatelet medication) was started * 6
- •month before inclusion of the patient, he/she will still be included in the
- •study. This protocol was chosen in order to widely assure a stable situation on
- •the plaque(s), which avoids an overspill from this medication on the assumed
- •effects of the vitamin K supplementation.
- •* Age older than 18 years
- •* Signed informed consent provided
排除标准
- •* Antiplatelet or cholesterol lowering medication started in the past 6 months
- •* Chronic or paroxysmal atrial fibrillation
- •* Presence or scheduled coronary or carotid revascularisation procedure (e.g.
- •stent implantation, coronary artery bypass graft, balloon-dilatation,
- •endarterectomy, angioplasty)
- •* History of myocardial infarction or stroke
- •* Malignant disease (except for treated basal-cell or squamous cell carcinoma)
- •* Use of vitamin K antagonists or any other anticoagulation treatment
- •* A life-expectancy < 1 year
- •* Claustrophobia
- •* Presence of a pacemaker, intra-cardiac defibrillator, or metallic implant
- •(e.g. vascular clip, neuro-stimulator, cochlear implant)
- •* Body weight > 130kg or body habitus that does not fit into the gantry
- •* Pregnancy or wish to become pregnant in the near future
- •* Breast feeding
- •* (History of) metabolic or gastrointestinal disease
- •* Use of vitamin K-containing supplements or vitamin K-rich foods (i.e. soya)
- •* Chronic inflammatory disease
- •* Systemic treatment or topical treatment likely to interfere with evaluation
- •of the study parameters
研究者
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