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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03133949
Other study ID # PHRCIR09-DR-SCHMIDT
Secondary ID
Status Recruiting
Phase N/A
First received April 13, 2017
Last updated April 25, 2017
Start date July 8, 2010
Est. completion date July 8, 2020

Study information

Verified date April 2017
Source Centre Hospitalier Universitaire, Amiens
Contact Jean SCHMIDT, PhD
Phone +33322668230
Email schmidt.jean@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 206
Est. completion date July 8, 2020
Est. primary completion date July 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analyze the management of patients with aortic and retroperitoneal fibrosis 1 day
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