Arterial Wall Calcium Load in Pseudoxanthoma Elasticum

NCT ID: NCT01731080

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pseudoxanthoma Elasticum Type 2 Diabetes Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pseudoxanthoma Elasticum

Patients with genetically and clincally proven PXE

No interventions assigned to this group

chronic kidney disease

Type 2 diabetic patients with mediacalcosis and matched to PXE patients for gender and age (+/- 5 yrs).

No interventions assigned to this group

Diabetes

patients with chronic kidney disease and matched to PXE patients for gender and age (+/- 5 yrs).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yannick LE CORRE, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital of Angers, France

Locations

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University Hospital

Angers, Pays de la Loire Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yannick LE CORRE, MD

Role: CONTACT

Phone: 33(2)41.35.39.10

Email: [email protected]

Ludovic MARTIN, MD, PhD

Role: CONTACT

Phone: 33(2)41.35.34.19

Email: [email protected]

Facility Contacts

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Ludovic MARTIN, MD, PhD

Role: primary

Georges LEFTHERIOTIS, MD, PhD

Role: backup

Other Identifiers

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AOI-2011

Identifier Type: -

Identifier Source: org_study_id