Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS (MUSES)

February 21, 2016 updated by: Andreas P Diamantopoulos, Hospital of Southern Norway Trust

A Head-to-Head Comparison of Color Doppler Ultrasonography (CDUS) and Magnetic Resonance Angiography (MRA) in Patients With Systemic Large Vessel Vasculitis (sLVV) - A Cross Sectional Study

This study is a cross sectional comparison of the Color Doppler Ultrasonography (CDUS) and Magnetic Resonance Angiography (MRA) in patients diagnosed with sLVV. The supraaortic large vessels (aorta, carotid, subclavian, vertebral, and axillary arteries) and the temporal arteries of fifty patients suffering of sLVV will be examined by CDUS and MRA. The images will be evaluated by 2 blinded experts (one for CDUS and one for MRA). In addition, the intima media complex (IMC) thickness of the large vessels and temporal arteries will be measured by CDUS in 100 sex and age matched controls to the sLVV patients. Blood samples from patients and controls will be collected in order to perform genetic and cytokine analyses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed cross sectional study will recruit 50 patients diagnosed with sLVV. All patients recruited to this study will be referrals from outpatient clinic of the Department of Rheumatology, Hospital of Southern Norway Trust. The diagnosis will be based on previous CDUS, MRA, CTA and/or biopsies of the temporal arteries. The patients will be classified according to specific set of classification criteria for GCA (11) or TA (12). The patients will undergo a CDUS evaluation of the supraaortic large vessels and the temporal arteries. In addition, a thorough clinical assessment will be performed at the CDUS visit. A blood sample to test the acute phase response (CRP and ESR) and other biochemical parameters as part of standard care will also be collected.

Within one week after the CDUS evaluation, MRA of the thoracic aorta, the supra-aortic vessels and temporal artery will be performed. The images of both examinations will be uploaded anonymously in a database and two external experts blinded to the patients (one for CDUS and one for MRA) will evaluate the data. The completed evaluation form will be uploaded in the same database.

The ultrasound examination will be performed by using high-end equipment, a Siemens S-2000 with a high, or medium frequency linear (up to 18 MHz for the superficial vessels or medium frequency up to 13 MHz for the deeper vessels) or phased-array transducer (examination of the aorta). The supraaortic vessels and the thoracic aorta will be evaluated by Gadolinium contrast-enhanced T1-weighted spin echo sequence with fat saturation 1.5 Tesla MRI equipment.

In both examinations, a measurement of the intima-media complex (IMC) thickness will be performed. The highest IMC thickness measurement will be recorded in both longitudinal and transverse films (of >3 sec length both in B and color Doppler mode for CDUS). Positive examination will be considered a measurement of IMC thickness >1.5 mm for aorta, carotid, subclavian and >1.0mm for the vertebral and axillary arteries. For the temporal artery, the presence of halo (circumferential, hypoechoic thickness of IMC in transverse/longitudinal view) will be considered as a positive finding. Stenoses of more than 50% in both modalities will also be recorded. Retrograde flow of the vertebral arteries in CDUS examination will be also considered as a positive finding.

Additionally, 100 healthy individuals matched for sex and age to the sLVV patients will be examined in their supraaortic large vessels and temporal arteries by CDUS. The IMC thickness of the healthy individuals will be measured by CDUS, the recordings will be labeled and stored in a database at the Department of Rheumatology, Hospital of Southern Norway Trust, in Kristiansand.

The CDUS and MRA images will be submitted to external experts for evaluation by using a specific evaluation form (Appendix). Both the experts will be blinded to the clinical, laboratory and previous imaging findings of the patients.

In addition, the level of inflammatory cytokines, chemokines and vascular markers (e.g. Vascular Endothelial Growth Factor (VEGF) and Metalloproteinase (MMP) -9) in blood samples of the patients with sLVV will be measured and compared to healthy controls. Whole blood, plasma and serum samples stored at -70 oC will be analyzed for expression of a panel of inflammatory cytokines by Enzyme-linked immunosorbent assay (ELISA) or related methods. Total RNA will be prepared from whole blood. All the blood samples will be stored in Revmabiobank at Hospital of Southern Norway Trust in Kristiansand.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

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

  • Norway
      • Haugesund, Norway, 5504
        • Haugesund sanitetsforenings revmatismesykehus
      • Kristiansand S, Norway, 4604
        • Department of Rheumatology, Hospital of Southern Norway Trust

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

Description

Inclusion Criteria:

  1. Patients >18 years
  2. Diagnosis of large vessel vasculitis based on Ultrasonographic and/or Computed Tomography Angiography and/or Magnetic Resonance Angiography findings or biopsies of the temporal arteries
  3. Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis

Exclusion Criteria:

  1. Patients <18 years
  2. Moderate to severe kidney failure
  3. Known allergic reactions to contrast agents
  4. Inability to give informed consent

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Color Doppler Ultrasound (CDUS)
The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by color Doppler ultrasound
Device: Ultrasound
Active Comparator: Magnetic resonance angiography (MRA)
The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by Magnetic resonance angiography
Device: MRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV.
Time Frame: 12 months
CDUS is superior to MRA in the assessment of the abnormal IMC of supraaortic vessels and temporal artery and comparable to MRA in the assessment of proximal thoracic and abdominal aorta.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the the average IMC thickness of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals.
Time Frame: 12 months
An estimation of the average IMC thicknesses of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals by ultrasound and a comparison to those of patients with sLVV will be performed.
12 months
Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Hospital of Southern Norway Trust

Collaborators

University Medical Center Groningen
University of Freiburg
Medical Center for Rheumatology Berlin-Buch

Investigators

  • Principal Investigator: Andreas Diamantopoulos, MD, Departement of Rheumatology, Hospital of Southern Norway Trust

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, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

January 19, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 21, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNT-2013/1655

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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