Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy (EchoSpA)

October 28, 2016 updated by: Dr Maria-Atonietta D'AGOSTINO

Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy

The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis

Study Overview

Status

Completed

Conditions

Detailed Description

Spondylarthritis (SPA) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. Because the characteritic signs of SPA, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of SPA for the patient and the confirmed diagnosis can be very long (up to 8 years). Previous studies proved that patients who are affected by SPA are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. Ultrasonography in B mode combined with power Doppler (PDUS) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of SPA's symptomatology. Using PDUS as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of SpA and reduce the cost of diagnosis for patient and health insurances.

Study Type

Observational

Enrollment (Actual)

489

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne Billancourt, France, 92100
        • Ambroise Paré Hospital
      • Brest, France, 29200
        • Cavale Blanche Hospital
      • Caen, France, 14033
        • Côte de Nacre Hospital
      • Echirolles, France, 38434
        • South Hospital of Grenoble
      • Marseille, France, 13005
        • Conception hospital
      • VANDOEUVRE les NANCY, France, 54511
        • Nancy Brabois Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients with a symptomatology which can lead to a SPA diagnosis but with no confirmed diagnosis yet for any rheumatic didease.

Description

Inclusion Criteria:

  • patients < 50 years old, consulting for spinal inflammatory symptoms > 3 months duration
  • patients consulting for arthritis or tenderness joints > 3 months duration
  • patients < 50 years old consulting for enthesitis or dactylitis > 3 months duration
  • patients with uveitis and HLA-B27 positivity
  • relatives of SpA patients consulting for symptoms suggestive of SpA

Exclusion Criteria:

  • patient with confirmed diagnosis of rheumatic disease (included SpA)
  • patient protected by law (patient <18 years old, pregnant woman)
  • patient who can't atempt the RMI
  • patient who will have difficulties to complete the two years of follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Maria-Atonietta D'AGOSTINO

Collaborators

French Society of Rheumatology
Groupe Français d'Etude Génétique des Spondylarthropathies

Investigators

  • Principal Investigator: D'AGOSTINO Maria-Antonietta, MCUPH, Ambroise Paré Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GESPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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