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

November 14, 2012 updated by: University Hospital, Angers

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pays de Loire
      • Angers, Pays de Loire, France, 49933
        • Ludovic MARTIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Martin Ludovic, MD, PhD, Department of Dermatology, University Hospital of Angers, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-Promoteur 2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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