Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome | NCT00546013

Studies
Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome

NCT00546013

Sponsor

European Georges Pompidou Hospital

Status

Terminated

Last Update Posted

Oct 18, 2007Estimated

Enrollment

208Actual

Phase

Not provided

Conditions

Abdominal Aortic Aneurysms
Pseudoexfoliation Syndrome
Hypertension

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

all patients required included

Expanded Access Info

Start Date

Dec 2001

Primary Completion Date

Not provided

Completion Date

Jul 2002Actual

First Submitted Date

Oct 17, 2007

First Submission Date that Met QC Criteria

Oct 17, 2007

First Posted Date

Oct 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2007

Last Update Posted Date

Oct 18, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Label	Type	Description	Intervention Names
AAA group, control group		AAA group : with AAA Control group: without AAA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
standard ophthalmologic examination to group patients according to their pseudoexfoliation status		Day of standard ophthalmologic examination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of abdominal aortic aneurism
Systemic hypertension without abdominal aortic aneurism over 60 years old

Exclusion Criteria:

Unknown status for abdominal aortic aneurism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

in patients suffering from abdominal aortic aneurism as part of a routine clinical yearly follow-up and hypertensive patients without abdominal aortic aneurism and that were more than 60 years old to have similar mean ages in both groups, as pseudoexfoliation and abdominal aortic aneurism are age-related disorders

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Rossignol, MD, PhD		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Européen Georges Pompidou		Paris		75015	France

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal
D017889	Exfoliation Syndrome
D006973	Hypertension
D005901	Glaucoma

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided