Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

NCT01795456 | Completed

• 1 other identifier: 10-595
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Correlation between carotid IMT and neovascularization and disease activity

  3 days

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• GE Healthcare: collaborator

Study Sites (1)

Cleveland Clinic Main Campus, Section of Vascular Medicine

Cleveland, Ohio, 44011, United States

Location

MeSH Terms

Conditions

Takayasu Arteritis; Giant Cell Arteritis; Arteritis; Vasculitis; Aortitis; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Soo Hyun Kim, MD, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: August 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)