coronary atherosclerosis coronary calcification
Conditions
Interventions
Daily oral capsule containing 360 micrograms of menaquinone-7 (Vitamin K2) or a
daily placebo-capsule that is identical to the other intervention except for
the presence of menaquinone-7.
Sponsors
Interne Geneeskunde
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age 18 years or older - Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality - Baseline Agatston calciumscore 50 - 400
Exclusion criteria
Exclusion criteria: - Baseline-scan of insufficient quality (due to the presence of motion artefacts, breathing artefacts or high noise-levels) - Heart rate greater than 70 beats per minute during first scan.(despite adequeate treatment with metoprolol) - Chronic or paroxysmal Atrial Fibrillation - Presence or scheduled coronary revascularization procedure (balloon-dilatation or stent-placement in more than one artery or bypass-grafting). - History of myocardial infarction or stroke within the last 6 months before CT-scan. - Presence of Diabetes Mellitus type 1 - Known kidney disease or a Glomerular Filtration Rate (GFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of Coronary Artery Calcification (CAC) expressed in Agatston units and Mass-score; measured by 128-slice Multidetector CT after 12 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of calcified coronary atherosclerotic lesions after 24 months of follow-up measured by Coronary CT-angiography. - Change in parameters of arterial stiffness: Pulse-Wave Velocity, central Aortic Blood-pressure and systolic blood-pressure. - Change in the carotid Intima Media Thickness after 12 and 24 months of follow-up. - Biochemical changes in blood-markers of calcification such as Matrix Gla Protein and Osteocalcin | — |
Countries
Netherlands
Outcome results
None listed