Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01795456

Collaborator

GE Healthcare (Industry)

Enrollment

Location

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Takayasu's Arteritis Giant Cell Arteritis Arteritis Vasculitis Aortitis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Outcome Measures

Primary Outcome Measures

Correlation between carotid IMT and neovascularization and disease activity [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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)