Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

Contrast Enhanced Ultrasound for Assessment of Carotid Artery Neovascularization as a Marker of Disease Activity in Takayasu's Arteritis and Giant Cell Arteritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01795456

Enrollment

Registered

2013-02-20

Start date

2010-08-31

Completion date

2014-01-31

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortitis, Arteritis, Giant Cell Arteritis, Takayasu's Arteritis, Vasculitis

Keywords

Takayasu's arteritis, Giant Cell arteritis, Arteritis, Vasculitis, Aortitis, Disease Activity, Carotidynia, Neovascularization, Carotid Intima Media Thickness

Brief summary

The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant Cell arteritis and to determine if patients with active arteritis have a thickening of their blood vessel walls compared to healthy people of the same age and gender.

Detailed description

Takayasu's arteritis and Giant Cell arteritis are chronic, relapsing diseases of the large arteries which can lead to significant narrowing of the arteries through episodes of inflammation within the artery walls. The changes in the vessel walls will be determined by an ultrasound test looking at and measuring: carotid vessel wall changes called carotid Intimal-Media Thickness (cIMT) and the presence of new blood vessels (neovascularization) using a contrast agent. Ultrasound findings will be correlated with markers of inflammation in the blood, findings from other radiology studies (such as MRI) already ordered as part of routine clinical care, and physical exam findings and symptoms of consistent with disease activity. 15 arteritis patients and 5 healthy controls will be recruited.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

Inclusion criteria

* Male and female patients \>18 years * Diagnosis of Takayasu's arteritis or giant cell arteritis * Suspicion of common carotid involvement on the basis of physical examination (cervical bruit), carotidynia, documented CCA involvement on an imaging study (MRA, CTA, or ultrasound), or documented upper extremity large vessel involvement on an imaging study (MRA or CTA or ultrasound). * Ability to provide informed consent

Exclusion criteria

* Prior stroke, carotid surgery or angioplasty * Pregnant (or trying to become pregnant) * Nursing * Known or suspected cardiac shunt * Documented hypersensitivity to the contrast agent * Severe pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, or respiratory failure)

Design outcomes

Primary

Measure	Time frame
Correlation between carotid IMT and neovascularization and disease activity	3 days

Countries

United States

Outcome results