跳至主要内容
临床试验/NCT02042092
NCT02042092已完成不适用

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

Hospital of Southern Norway Trust4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
4
主要终点
Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 years
  • 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
  • Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis

排除标准

  • Patients <18 years
  • Moderate to severe kidney failure
  • Known allergic reactions to contrast agents
  • Inability to give informed consent

结局指标

主要结局

Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV.

时间窗: 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.

次要结局

  • Measurement of the the average IMC thickness of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals.(12 months)
  • Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals(12 months)

研究者

发起方
Hospital of Southern Norway Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas P Diamantopoulos

Consultant Rheumatologist

Hospital of Southern Norway Trust

研究点 (4)

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