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Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01795456
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : January 27, 2017
GE Healthcare
Information provided by (Responsible Party):
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.

Condition or disease
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.

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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 : August 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Primary Outcome Measures :
  1. Correlation between carotid IMT and neovascularization and disease activity [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01795456

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United States, Ohio
Cleveland Clinic Main Campus, Section of Vascular Medicine
Cleveland, Ohio, United States, 44011
Sponsors and Collaborators
The Cleveland Clinic
GE Healthcare
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Principal Investigator: Soo Hyun Kim, MD, MPH The Cleveland Clinic

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Responsible Party: The Cleveland Clinic Identifier: NCT01795456     History of Changes
Other Study ID Numbers: 10-595
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Cleveland Clinic:
Takayasu's arteritis
Giant Cell arteritis
Disease Activity
Carotid Intima Media Thickness
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Neovascularization, Pathologic
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Aortic Diseases