VCRC Longitudinal Protocol for Aortitis

Completed

• Conditions: Aortitis

• Registration Number: NCT03022331
• Lead Sponsor: University of Pennsylvania

Brief Summary

The term 'aortitis' refers to inflammation of the aorta. Aortitis is known to occur in a variety of vasculitides and connective tissue diseases, such as giant cell arteritis (GCA), Takayasu arteritis (TAK), rheumatoid arthritis, and spondyloarthropathies, among others. This study will establish a longitudinal cohort for these diseases.

Detailed Description

This study will develop a longitudinal cohort of patients with different types of aortitis to systematically study the natural history, optimal treatments, and outcomes in this group of diseases. This will provide a resource for future studies and for identification of new biomarkers of aortitis for purposes of diagnosis, disease activity measurement, disease damage assessment, determination of disease states, and evaluation of treatment response.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Study Start: 2017-12-04
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Subjects will be included if they meet one of the following criteria:

1. Previous or current microscopic evidence of aortitis (active or healed) on surgical specimen obtained during aortic resection
2. Previous or current radiographic aortitis that could include circumferential aortic wall thickening of at least 3mm on CT or MRI or increased PET FDG uptake in the aorta at values equal to or greater than the liver, in absence of an alternative explanation for the radiographic findings.

Exclusion

1. Subjects already enrolled in one of the other VCRC longitudinal cohorts: 5502, 5503, 5504, 5505, and 5506.
2. Inability of participants (or their guardians in the case of children) to give informed consent and to sign the consent form.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phenotypic correlates of genotype	5 years	Using longitudinally collected phenotypic data, this project aims to define the natural history (i.e. biochemical evidence of systemic inflammation, and systemic symptoms) of different types of phenotypes of aortitis and related disorders in patients using serum and genetic information collected through specimens.

Trial Locations

Locations (10)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Boston University; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University British Columbia/Mary Pack Arthritis Centre; 🇨🇦 Vancouver, British Columbia, Canada

University of Toronto, Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada