Status:
UNKNOWN
Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease
Lead Sponsor:
Academisch Ziekenhuis Maastricht
Collaborating Sponsors:
Horizon 2020 - European Commission
Conditions:
Coronary Artery Disease
Carotid Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atherosclerosis is a disease of the arteries and is the result of various factors such as high blood cholesterol or diabetes, which lead to accumulations of fats, cells, and calcium deposits (i.e. pla...
Eligibility Criteria
Inclusion
- 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, if intensified medical treatment for this symptomatic stenosis (e.g. statins, antiplatelet medication) was started ≥ 6 month before inclusion of the patient. 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 MK-7 and vitamin D3 supplementation.
- Age older than 18 years
- Signed informed consent provided
Exclusion
- Antiplatelet or cholesterol lowering medication started within 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 or D 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
- Corticoid treatment
- Participation in a clinical study more recently than one month before the current study
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04010578
Start Date
January 1 2024
End Date
April 1 2025
Last Update
September 21 2023
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