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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01731080
First received: November 14, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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).
Diabetes
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.

  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

Pseudoxanthoma Elasticum (PXE)

Criteria

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 ClinicalTrials.gov identifier: NCT01731080

Contacts
Contact: Yannick LE CORRE, MD 33(2)41.35.39.10 yalecorre@chu-angers.fr
Contact: Ludovic MARTIN, MD, PhD 33(2)41.35.34.19 lumartin@chu-angers.fr

Locations
France
University Hospital Recruiting
Angers, Pays de la Loire, France, 49933
Contact: Ludovic MARTIN, MD, PhD    33(2)41.35.34.19    lumartin@chu-angers.fr   
Contact: Georges LEFTHERIOTIS, MD, PhD    33(2)41.35.44.56    geleftheriotis@chu-angers.fr   
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
Investigators
Principal Investigator: Yannick LE CORRE, MD Department of Dermatology, University Hospital of Angers, France
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01731080     History of Changes
Other Study ID Numbers: AOI-2011
Study First Received: November 14, 2012
Last Updated: November 20, 2012
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Pseudoxanthoma Elasticum
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
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
Renal Insufficiency

ClinicalTrials.gov processed this record on July 28, 2014