The effects of Vitamin K2 supplementation on the progression of Coronary Artery Calcificatio

Phase 2

Recruiting

Conditions: coronary atherosclerosis
coronary calcification
10011082
10057166

Registration Number: NL-OMON46941

Lead Sponsor: Interne Geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

- age 18 years or older
- Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
- Baseline Agatston calciumscore 50 - 400

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) < 60 ml/min/1.73m2 calculated by the MDRD-formula (Levene; 2001).
- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression of Coronary Artery Calcification (CAC) expressed in Agatston units<br /><br>and Mass-score; measured by 128-slice Multidetector CT after 12 and 24 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Evaluation of calcified coronary atherosclerotic lesions after 24 months of<br /><br>follow-up measured by Coronary CT-angiography.<br /><br>- Change in parameters of arterial stiffness: Pulse-Wave Velocity, central<br /><br>Aortic Blood-pressure and systolic blood-pressure.<br /><br>- Change in the carotid Intima Media Thickness after 12 and 24 months of<br /><br>follow-up.<br /><br>- Biochemical changes in blood-markers of calcification such as Matrix Gla<br /><br>Protein and Osteocalcin</p><br>