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Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01795456
First Posted: February 20, 2013
Last Update Posted: January 27, 2017
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.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
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
Takayasu's Arteritis Giant Cell Arteritis Arteritis Vasculitis Aortitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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

Enrollment: 7
Actual Study Start Date: August 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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.
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01795456


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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01795456     History of Changes
Other Study ID Numbers: 10-595
First Submitted: February 18, 2013
First Posted: February 20, 2013
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
Arteritis
Vasculitis
Aortitis
Disease Activity
Carotidynia
Neovascularization
Carotid Intima Media Thickness

Additional relevant MeSH terms:
Giant Cell Arteritis
Neovascularization, Pathologic
Vasculitis
Arteritis
Polymyalgia Rheumatica
Takayasu Arteritis
Aortic Arch Syndromes
Aortitis
Metaplasia
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