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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01446393
First received: October 3, 2011
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Pseudoxanthoma Elasticum

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Functional and Structural Characterization of the Peripheral Arteriopathy in Pseudoxanthoma Elasticum (PXE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Biospecimen Retention:   Samples With DNA

Blood samples for genetic and serum analysis


Enrollment: 71
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with phenotypically and genetically (ABCC6) proved PXE and Control patients paired for age (+/- 5 yeas) and gender.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446393

Locations
France
Ludovic MARTIN
Angers, Pays de Loire, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Martin Ludovic, MD, PhD Department of Dermatology, University Hospital of Angers, France
  More Information

Publications:

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01446393     History of Changes
Other Study ID Numbers: CHU-Promoteur 2010-01
Study First Received: October 3, 2011
Last Updated: November 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Pseudoxanthoma Elasticum
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
 Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013