Arterial Wall Calcium Load in Pseudoxanthoma Elasticum

Type 2 Diabetes Clinical Trial

— Ca-Art-PXE2  

Official title:

Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01731080
• Other study ID #: AOI-2011
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2012
• Last updated: November 20, 2012
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2012
• Source: University Hospital, Angers
• Contact: Yannick LE CORRE, MD
• Phone: 33(2)41.35.39.10
• Email: yalecorre[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Pseudoxanthoma Elasticum
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Locations

Country	Name	City	State
France	University Hospital	Angers	Pays de la Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calcification score	the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score	after inclusion	No
Secondary	site of calcification	the anatomical site of arterial wall calcification determined by a Ct-scan and computed by the Agatston score	after inclusion	No