Clinical trial NCT01795456: Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takayasu's Arteritis
Giant Cell Arteritis
Arteritis
Vasculitis
Aortitis
Keywords: Takayasu's arteritis
Giant Cell arteritis
Arteritis
Vasculitis
Aortitis
Disease Activity
Carotidynia
Neovascularization
Carotid Intima Media Thickness
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2013-02-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Takayasu's arteritis or giant cell arteritis will be screened from the clinics of the Vasculitis Clinic and the Vascular Medicine Clinic at 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correlation between carotid IMT and neovascularization and disease activity
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus, Section of Vascular Medicine
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Soo Hyun Kim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: