NCT02823093

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

April 25, 2016

Last Update Submit

January 30, 2017

Conditions

Vascular Calcification

Keywords

vascular calcificationaortic calcificationvitamin K antagonistfluindionewarfarinmatrix 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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

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: 6607731BACKGROUND

  • 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: 15265793BACKGROUND

  • 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: 9743228BACKGROUND

  • 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: 18841280BACKGROUND

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)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Cedric RENARD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Liabeuf, Dr

CONTACT

liabeuf.sophie@chu-amiens.fr

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 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

FR(1)