Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by The Cleveland Clinic.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Soo Hyun (Esther) Kim, The Cleveland Clinic
First received: February 18, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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.
Giant Cell Arteritis
||Observational Model: Case Control
Time Perspective: Prospective
||Contrast Enhanced Ultrasound for Assessment of Carotid Artery Neovascularization as a Marker of Disease Activity in Takayasu's Arteritis and Giant Cell Arteritis
Primary Outcome Measures:
- Correlation between carotid IMT and neovascularization and disease activity [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- Prior stroke, carotid surgery or angioplasty
- Pregnant (or trying to become pregnant)
- 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01795456
|Cleveland Clinic Main Campus, Section of Vascular Medicine
|Cleveland, Ohio, United States, 44011 |
|Contact: Neil Poria, BS, MA 216-444-0334 |
The Cleveland Clinic
No publications provided
||Soo Hyun (Esther) Kim, Staff physician, The Cleveland Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 18, 2013
||February 18, 2013
||United States: Food and Drug Administration
Keywords provided by The Cleveland Clinic:
Giant Cell arteritis
Carotid Intima Media Thickness
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Giant Cell Arteritis
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Vasculitis, Central Nervous System