Completed

Contrast Enhanced Ultrasound for Assessment of Carotid Artery Neovascularization as a Marker of Disease Activity in Takayasu's Arteritis and Giant Cell Arteritis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Aortic Arch Syndromes+21

+ Aortic Diseases

+ Autoimmune Diseases

From 18 to 100 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: August 2010
See protocol details

Summary

Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01795456
Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Arch SyndromesAortic DiseasesAutoimmune DiseasesBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersImmune System DiseasesMetaplasiaNervous System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsVascular DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularAutoimmune Diseases of the Nervous SystemVasculitis, Central Nervous SystemAortitisArteritisNeovascularization, PathologicTakayasu ArteritisGiant Cell ArteritisVasculitis

Criteria

4 inclusion criteria required to participate
Ability to provide informed consent
Diagnosis of Takayasu's arteritis or giant cell arteritis
Male and female patients > 18 years
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)
6 exclusion criteria prevent from participating
Documented hypersensitivity to the contrast agent
Known or suspected cardiac shunt
Nursing
Pregnant (or trying to become pregnant)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cleveland Clinic Main Campus, Section of Vascular Medicine

Cleveland, United StatesOpen Cleveland Clinic Main Campus, Section of Vascular Medicine in Google Maps
CompletedOne Study Center