CClinicalTrials.gg
CompletedNCT01795456Updated Jan 27, 2017

Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

An observational study in Takayasu's Arteritis, Giant Cell Arteritis and Arteritis, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-27.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
7
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Polymyalgia Rheumatica

135 studies on the registry are indexed under Polymyalgia Rheumatica; 28 are open to participants now.

This study's enrollment of 7 is below the median of 114 across 65 observational studies indexed under Polymyalgia Rheumatica.

Browse Polymyalgia Rheumatica studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
7 participants (actual)
06

What researchers measure

Primary outcomes

  1. Correlation between carotid IMT and neovascularization and disease activity

    Time frame: 3 days

07

Study locations

1 site
  • Cleveland Clinic Main Campus, Section of Vascular Medicine
    Cleveland, Ohio 44011, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01795456
Lead sponsor
The Cleveland Clinic
Collaborators
GE Healthcare
Responsible party
Sponsor
First posted
Feb 20, 2013
Start date
Aug 2010
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Jan 27, 2017

Study contacts

Soo Hyun Kim, MD, MPH
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion