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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospital of Southern Norway Trust
Sponsor:
Collaborators:
Medical Center for Rheumatology Berlin-Buch
University of Freiburg
University Medical Centre Groningen
Information provided by (Responsible Party):
Andreas P Diamantopoulos, Hospital of Southern Norway Trust
ClinicalTrials.gov Identifier:
NCT02042092
First received: December 27, 2013
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Systemic Vasculitis
Device: Ultrasound
Device: MRA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital of Southern Norway Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042092

Contacts
Contact: Andreas P Diamantopoulos, MD +4738073155 andreas.diamantopoulos@sshf.no

Locations
Norway
Department of Rheumatology, Hospital of Southern Norway Trust Recruiting
Kristiansand S, Norway, 4604
Contact: Andreas P Diamantopoulos, MD    +4738073155    andreas.diamantopoulos@sshf.no   
Principal Investigator: Andreas P Diamantopoulos, MD         
Sponsors and Collaborators
Hospital of Southern Norway Trust
Medical Center for Rheumatology Berlin-Buch
University of Freiburg
University Medical Centre Groningen
Investigators
Principal Investigator: Andreas Diamantopoulos, MD Departement of Rheumatology, Hospital of Southern Norway Trust
  More Information

Publications:

Responsible Party: Andreas P Diamantopoulos, Consultant Rheumatologist, Hospital of Southern Norway Trust
ClinicalTrials.gov Identifier: NCT02042092     History of Changes
Other Study ID Numbers: SNT-2013/1655
Study First Received: December 27, 2013
Last Updated: January 19, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Hospital of Southern Norway Trust:
Ultrasound
MRA
Large Vessel Vasculitis
Giant Cell Arteritis
Takayasu Arteritis
Immunological abnormalities

Additional relevant MeSH terms:
Vasculitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014