Functional and Structural Characterization of Arteriopathy in Pseudoxanthoma Elasticum (PXE)

Pseudoxanthoma Elasticum Clinical Trial

— Ca-Art-PXE  

Official title:

Functional and Structural Characterization of the Peripheral Arteriopathy in Pseudoxanthoma Elasticum (PXE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446393
• Other study ID #: CHU-Promoteur 2010-01
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: November 14, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

To determine the specific structural and functional features of the peripheral arteriopathy in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.

Description:

The primary objective of this study is to characterize the structural and functional characteristics of the peripheral arteries (lower and upper limbs) . a secondary objective will be to determine the arterial calcification using CT-scan as a useful tools for the diagnosis and the follow-up of this disease. Data will be collected from a cohort of patients PXE monitored in our Health and Research PXE center at the University Hospital of Angers. The structural and functional variables of the distal arteries (radial and tibialis arteries) will be studied using high-resolution echography. Scoring of the arterial calcium load will be determined by helicoidal CT-scan in the lower limb arteries. These variables will be compared to matched (gender and age) controls without PXE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with phenotypically and genetically (ABCC6) proved PXE or control patients paired for age and gender

• Written formed consent obtained

• Patient affiliated to a Health care system

Exclusion Criteria:

• Patient with unproved PXE

• Pregnant woman

• Patient unwilling to participate to the study

• Not affiliated to a Health care System

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pseudoxanthoma Elasticum

Locations

Country	Name	City	State
France	Ludovic MARTIN	Angers	Pays de Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

Martin L, Maître F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301. — View Citation

Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9. — View Citation