Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Arterial Wall Calcium Load in Pseudoxanthoma Elasticum (Ca-Art-PXE2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by University Hospital, Angers.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Angers Identifier:
First received: November 14, 2012
Last updated: November 20, 2012
Last verified: November 2012
Quantification and preferential sites of arterial wall calcification within the coronary and lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2 diabetics and Chronic Kidney disease.

Pseudoxanthoma Elasticum
Type 2 Diabetes
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.

Resource links provided by NLM:

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • calcification score [ Time Frame: after inclusion ]
    the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score

Secondary Outcome Measures:
  • site of calcification [ Time Frame: after inclusion ]
    the anatomical site of arterial wall calcification determined by a Ct-scan and computed by the Agatston score

Biospecimen Retention:   Samples With DNA
Blood samples

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Pseudoxanthoma Elasticum
Patients with genetically and clincally proven PXE
chronic kidney disease
Type 2 diabetic patients with mediacalcosis and matched to PXE patients for gender and age (+/- 5 yrs).
patients with chronic kidney disease and matched to PXE patients for gender and age (+/- 5 yrs).

Detailed Description:

In a previous work we have observed that patients suffering from PXE, a soft-tissue calcifying inherited autosomal disease, exhibited specific structural and functionnal features within the peripheral arteries. We now want to quantify and determine the preferential sites of the arterial wall calcification (Agatston score) between these patients compared to diabetics and patients with chronic renal insufficiency with mediacalcosis.

All variables will be collected from a cohort of PXE monitored in our PXE Health and Care centre at the university hospital of Angers. Quantification of the arterial wall calcium load will be performed using helicoidal CT-scan. These variables will be compared to the same measurements performed in type 2 diabetic and chronic kidney disease patients paired by age and gender.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pseudoxanthoma Elasticum (PXE)

Inclusion Criteria:

  • Patients with phenotypically and genotypically-proven PXE
  • Type 2 diabetic patients with mediacalcosis (i.e. Ankle Brachial Index > 1.30)
  • Patients with a chronic kidney disease (CKD), before kidney transplantation
  • All patients should be affiliated to a Health care system

Exclusion Criteria:

  • Patient with unproved PXE
  • Patient under the age of 18 yrs
  • Patient unwilling to participate to the study
  • Pregnant women
  • Patient not affiliated to a Health care system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731080

Contact: Yannick LE CORRE, MD 33(2)
Contact: Ludovic MARTIN, MD, PhD 33(2)

University Hospital Recruiting
Angers, Pays de la Loire, France, 49933
Contact: Ludovic MARTIN, MD, PhD    33(2)   
Contact: Georges LEFTHERIOTIS, MD, PhD    33(2)   
Principal Investigator: Yannick LE CORRE, MD         
Sub-Investigator: Ludovic MARTIN, MD, PhD         
Sub-Investigator: Georges LEFTHERIOTIS, MD, PhD         
Sub-Investigator: Pierre ABRAHAM, MD, PhD         
Sub-Investigator: Serge WILLOTEAUX, MD, PhD         
Sub-Investigator: Jean-Francois SUBRA, MD, PhD         
Sub-Investigator: Pierre-Henri DUCLUZEAU, MD         
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Yannick LE CORRE, MD Department of Dermatology, University Hospital of Angers, France
  More Information

Responsible Party: University Hospital, Angers Identifier: NCT01731080     History of Changes
Other Study ID Numbers: AOI-2011
Study First Received: November 14, 2012
Last Updated: November 20, 2012

Additional relevant MeSH terms:
Pseudoxanthoma Elasticum
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
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 processed this record on May 22, 2017