Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria

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.

Study Overview

• Status: Unknown
• Conditions: Retroperitoneal Fibrosis; Idiopathic Aortitis
• Intervention / Treatment: Other: Establish the clinical, biological and radiological characteristics of patients

• Study Type: Observational
• Enrollment (Anticipated): 206

Contacts and Locations

• Study Contact: Name: Jean SCHMIDT, PhD; Phone Number: +33322668230; Email: schmidt.jean@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Jean SCHMIDT, PhD; Phone Number: +33322668230; Email: schmidt.jean@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analyze the management of patients with aortic and retroperitoneal fibrosis	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2010
• Primary Completion (Anticipated): July 8, 2020
• Study Completion (Anticipated): July 8, 2020

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Vasculitis; Aortic Diseases; Fibrosis; Retroperitoneal Fibrosis; Aortitis
• Other Study ID Numbers: PHRCIR09-DR-SCHMIDT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No