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Clinical Trials/NL-OMON47825
NL-OMON47825
Completed
Not Applicable

Bicuspid aortic valve stenosis and the effect of vItamin K2 on calciummetabolism on 18F-NaF PET/MRI (BASIK2): a pilot study - BASIK2

Medisch Universitair Ziekenhuis Maastricht0 sites44 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic valve calcification
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
44
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
February 1, 2021
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • Known with a bicuspid aortic valve and,
  • Calcified mild to moderate aortic valve stenosis on prior echocardiography
  • Age older than 18 years
  • Informed consent provided.

Exclusion Criteria

  • Absence of calcified aortic valve stenosis on echocardiography, presence of severe aortic valve stenosis, history of aortic valve repair or aortic valve replacement , scheduled for aortic valve replacement or repair , accepted atrial fibrillation, use of oral anticoagulants, claustrophobia, presence of a pacemaker or ICD or ferromagnetic materials in the body, adipositas permagna, history of (non treated) cancer within the previous two years (excep non\-melanoma skin cancer, carcinomas or in situ carcinoma of cervix), life expectancy of less than 2 years, wish for near future, or present pregnancy, breast feeding, (active) metabolic or gastrointestinal disease not controlled by current treatment, (history of) soy allergy, use of vitamin K\-containing supplements, 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.

Outcomes

Primary Outcomes

Not specified

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