Clinical trial NCT03022331: VCRC Longitudinal Protocol for Aortitis
Official title: VCRC Longitudinal Protocol for Aortitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortitis
Keywords: Idiopathic aortitis
Isolated aortitis
Vasculitis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-01-16
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 250 patients with aortitis will be enrolled into the VCRC longitudinal observational cohort study and followed for up to ten years. The study will be conducted at major vasculitis centers in North America, utilizing the Clinical and Translational Science Center (CTSC) at each site.

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.

Eligibility 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.

Primary outcomes:
measure: Phenotypic correlates of genotype
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Vancouver
country: Canada
facility: University British Columbia/Mary Pack Arthritis Centre
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto, Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Nataliya Milman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Peter A Merkel, MD, MPH
role: STUDY_DIRECTOR
References: