Effects of vitamin K2 supplementation on [18]F-NaF PET/MRI in patients with carotid and coronary artery disease

Conditions: carotid artery disease
narrowing of the arteries of the neck
10003216

Registration Number: NL-OMON47981

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

* * 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

Exclusion Criteria

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We hypothesize that intervention with vitamin K2 will lead to a regression or<br /><br>at least to non-progression of micro-calcifications compared to treatment with<br /><br>a placebo. Therefore, the main parameter/end point of this study is The main<br /><br>parameter/end point of this study is the mean rate of progression of vascular<br /><br>micro-calcifications in the carotid arteries, measured as a difference between<br /><br>the intervention group and placebo group in 18F-NaF uptake via hybrid PET/MRI<br /><br>at baseline and after the 3 months follow-up.</p><br>

Secondary Outcome Measures