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Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria

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ClinicalTrials.gov Identifier: NCT03133949
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience accumulated over the last ten years, shared by the experts of the subject, is that the initial clinical, biological or radiological characteristics should make it possible to differentiate them and dismember the Nosological field.

This will be an essential first step before studying prognosis, risk factors, and therapeutic options.

The search for diagnostic criteria on a large series, similar to the study of classification of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for the different teams working on the subject, and to begin work Collaborations, which alone can improve patient care in the future.


Condition or disease Intervention/treatment
Idiopathic Aortitis Retroperitoneal Fibrosis Other: Establish the clinical, biological and radiological characteristics of patients

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Study Type : Observational
Estimated Enrollment : 206 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria
Actual Study Start Date : July 8, 2010
Estimated Primary Completion Date : July 8, 2020
Estimated Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with idiopathic inflammatory aortitis Other: Establish the clinical, biological and radiological characteristics of patients
Establish the clinical, biological and radiological characteristics of patients

a group of witnesses Other: Establish the clinical, biological and radiological characteristics of patients
Establish the clinical, biological and radiological characteristics of patients




Primary Outcome Measures :
  1. Analyze the management of patients with aortic and retroperitoneal fibrosis [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with idiopathic inflammatory aortitis or retroperitoneal fibrosis.

Three focus groups will be constituted:

Group 1: it will include all cases of non-idiopathic inflammatory aortitis followed in the participating centers over the last 15 years, Group 2: it will include patients with non-inflammatory aortic conditions (aneurysm, atheroma, annulo-ectasitic aortic disease).

Group 3: it will include patients without aortic pathology matched by age and sex, having a thoracoabdominal scanner or MRI in the participating centers.

Criteria

Inclusion Criteria:

  • Cases :

    • All cases of idiopathic aortitis and retroperitoneal fibrosis followed in participating centers over the past 15 years will be collected.
  • Witnesses :

    • Group 1: non-idiopathic inflammatory aortitis: all cases of inflammatory aortitis (apart from idiopathic aortites and isolated retroperitoneal fibrosis) followed in the participating centers over the last 15 years will be collected.
    • Group 2: subjects with noninflammatory aortic disease, atheromatous type or annulo-ectasitic disease, matched by age and sex with cases. This group will be used to define the differential characteristics between idiopathic aortitis and noninflammatory aortic pathology.
    • Group 3: This group will include control subjects aimed at defining radiological normality criteria according to age and sex. As the images are machine-dependent, group 3 controls will be randomly selected from the radiology departments that have performed the scanner or MRI of the corresponding control.

Exclusion Criteria:

  • Patients under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133949


Contacts
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Contact: Jean SCHMIDT, PhD +33322668230 schmidt.jean@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Jean SCHMIDT, PhD    +33322668230    schmidt.jean@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03133949     History of Changes
Other Study ID Numbers: PHRCIR09-DR-SCHMIDT
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortitis
Fibrosis
Retroperitoneal Fibrosis
Pathologic Processes
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis