Pseudoxanthoma ElasticumCa-Art-PXE2NCT01731080
Arterial Wall Calcium Load in Pseudoxanthoma Elasticum
An observational study of Pseudoxanthoma Elasticum and Type 2 Diabetes, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudoxanthoma Elasticum, Type 2 Diabetes, Chronic Kidney Disease
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pseudoxanthoma Elasticum (PXE)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Angers, Pays de la Loire Region, 49933
Ludovic MARTIN, MD, PhD, 33(2)41.35.34.19, lumartin@chu-angers.fr
Georges LEFTHERIOTIS, MD, PhD, 33(2)41.35.44.56, geleftheriotis@chu-angers.fr
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pseudoxanthoma Elasticum, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcification score
the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score
Measured: after inclusion
Secondary outcomes (1)
site of calcification
the anatomical site of arterial wall calcification determined by a Ct-scan and computed by the Agatston score
Measured: after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoxanthoma ElasticumStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yannick LE CORRE, MD, Principal investigator, Department of Dermatology, University Hospital of Angers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731080
- Sponsor's protocol ID
- AOI-2011
- Acronym
- Ca-Art-PXE2
- Status last verified
- Nov 2012
- First submitted
- 14 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT01731080
- Acronym / sponsor ID
- Ca-Art-PXE2 / AOI-2011
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pseudoxanthoma Elasticum (PXE)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
calcification score
Time frame: after inclusion
the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score
1 secondary outcome
site of calcification
Time frame: after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick LE CORRE, MD principal investigator
Department of Dermatology, University Hospital of Angers, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoxanthoma Elasticum and Type 2 Diabetes, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick LE CORRE, MD (33(2)41.35.39.10, yalecorre@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calcification score (time frame: after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.