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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University Hospital, Angers.
Recruitment status was  Recruiting
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

November 14, 2012
November 20, 2012
January 2012
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01731080 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Arterial Wall Calcium Load in Pseudoxanthoma Elasticum
Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

Pseudoxanthoma Elasticum (PXE)

  • Pseudoxanthoma Elasticum
  • Type 2 Diabetes
  • Chronic Kidney Disease
Not Provided
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01731080
AOI-2011
Yes
University Hospital, Angers
University Hospital, Angers
Not Provided
Principal Investigator: Yannick LE CORRE, MD Department of Dermatology, University Hospital of Angers, France
University Hospital, Angers
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP