Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

Completed

• Conditions: Giant Cell Arteritis; Arteritis; Vasculitis; Takayasu's Arteritis; Aortitis

• Registration Number: NCT01795456
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between carotid IMT and neovascularization and disease activity	3 days

Trial Locations

Locations (1)

Cleveland Clinic Main Campus, Section of Vascular Medicine; 🇺🇸 Cleveland, Ohio, United States