VCRC Longitudinal Protocol for Aortitis

University of Pennsylvania

Status: Completed

Conditions: Aortitis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03022331

VCRC5507

U54AR057319 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

16 participants in 1 patient group

Observational