Arterial Wall Calcium Load in Pseudoxanthoma Elasticum (Ca-Art-PXE2)
This study is currently recruiting participants.
Verified November 2012 by University Hospital, Angers
Sponsor:
University Hospital, Angers
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
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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
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 June 13, 2013