Aortic Calcification and Vitamin K Antagonists

NCT02823093 | Completed

• 1 other identifier: PI2015_843_0025
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic calcifications development. This is a biomedical research without health product, transversal and monocentric study which compares the aortic calcifications levels of two populations : one treated by VKA and the other which has never been treated by VKA.

Conditions

Vascular Calcification

Keywords

vascular calcification; aortic calcification; vitamin K antagonist; fluindione; warfarin; matrix gla protein

Outcome Measures

Primary Outcomes (1)

• Calcifications scores

  Agatston's method

  at inclusion

Secondary Outcomes (1)

• Plasmatic concentrations in dp-ucMGP

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One group treated by VKA treatment for at least 6 months and one focus droup which have never been treated by VKA treatment.

You may qualify if:

• patients having a abdominal scanner without injection planned at CHU Amiens
• group treated by VKA: VKA treatment for at least 6 months
• group not treated by VKA: no antecedent of AVK treatment

You may not qualify if:

• abdominal scanner contre indication
• progressive cancer
• scanner planned by emergency department
• patient having had acute cardiovascular accident in the last 3 months

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (4)

• Price PA, Urist MR, Otawara Y. Matrix Gla protein, a new gamma-carboxyglutamic acid-containing protein which is associated with the organic matrix of bone. Biochem Biophys Res Commun. 1983 Dec 28;117(3):765-71. doi: 10.1016/0006-291x(83)91663-7.

  PMID: 6607731 BACKGROUND

• Schurgers LJ, Aebert H, Vermeer C, Bultmann B, Janzen J. Oral anticoagulant treatment: friend or foe in cardiovascular disease? Blood. 2004 Nov 15;104(10):3231-2. doi: 10.1182/blood-2004-04-1277. Epub 2004 Jul 20.

  PMID: 15265793 BACKGROUND

• Price PA, Faus SA, Williamson MK. Warfarin causes rapid calcification of the elastic lamellae in rat arteries and heart valves. Arterioscler Thromb Vasc Biol. 1998 Sep;18(9):1400-7. doi: 10.1161/01.atv.18.9.1400.

  PMID: 9743228 BACKGROUND

• Schurgers LJ, Cranenburg EC, Vermeer C. Matrix Gla-protein: the calcification inhibitor in need of vitamin K. Thromb Haemost. 2008 Oct;100(4):593-603.

  PMID: 18841280 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A tube of blood on EDTA tubes of 6 ml will be taken at the elbow to the Clinical Research Center and then frozen at -80 ° . At the end of the study the tubes of all patients will be routed to VetAgro Sup Lyon in dry ice. DNA will be extracted from EDTA tubes . It will be stored frozen in the laboratory until analysis of polymorphisms of interest, by PCR technique . The promoter and the coding sequence of VKORC1 will be amplified by PCR and sequenced to detect the possible presence of SNPs

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cedric RENARD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: July 6, 2016
• Study Start: April 19, 2016
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)