Coronary Artery Disease
Conditions
Keywords
Coronary Artery Calcification, Vitamin K, Trial, Treatment
Brief summary
Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events. The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause arterial calcification and a diet containing large amounts of Vitamin K2 was associated with lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2 caused regression of existing arterial calcification. Therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.
Interventions
DIETARY_SUPPLEMENTMenaquinone-7 (Vitamin K2)
Menaquinone-7 (Vitamin K2)
OTHERPlacebo capsules
Capsules containing no Menaquinone-7
Sponsors
VitaK
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality * Baseline Agatston calciumscore 100 - 400
Exclusion criteria
* Baseline-scan of insufficient quality * Heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol) * Chronic or paroxysmal Atrial Fibrillation * Presence or scheduled coronary revascularization procedure * History of myocardial infarction or stroke. * Presence of Diabetes Mellitus. * Known kidney disease or a Glomerular Filtration Rate (GFR)MDRD \< 60 ml/min/1.73m2 * Malignant disease (exception: treated basal-cell or squamous cell carcinoma). * Use of Vitamin K antagonists. * A life-expectancy \< 2 years * Pregnancy or wish to become pregnant in the near future.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coronary Artery Calcification-score progression | 12 and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity | 0, 12 and 24 months |
| Carotid Intima Media Thickness | 0, 12 and 24 months |
Countries
Netherlands
Outcome results
None listed