Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis
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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 |
- Correlation between carotid IMT and neovascularization and disease activity [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2010 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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)
Contacts and Locations| Contact: Neil Poria, BS,MA | 216-444-0334 | porian@ccf.org |
| Contact: Soo Hyun Kim, MD, MPH | 216-444-1680 | kims@ccf.org |
| United States, Ohio | |
| Cleveland Clinic Main Campus, Section of Vascular Medicine | Recruiting |
| Cleveland, Ohio, United States, 44011 | |
| Contact: Neil Poria, BS, MA 216-444-0334 | |
More Information
No publications provided
| Responsible Party: | Soo Hyun (Esther) Kim, Staff physician, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01795456 History of Changes |
| Other Study ID Numbers: | 10-595 |
| Study First Received: | February 18, 2013 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Polymyalgia Rheumatica Aortitis Arteritis Neovascularization, Pathologic Takayasu Arteritis Aortic Arch Syndromes Vasculitis Aortic Diseases Vascular Diseases Cardiovascular Diseases Metaplasia Pathologic Processes Skin Diseases, Vascular |
Skin 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 Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 23, 2013