Skip to main content
OpenTrials
Completed

NCT Number: NCT03022331

VCRC Longitudinal Protocol for Aortitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortitis Aortic Diseases Cardiovascular Diseases Vascular Diseases Vasculitis

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University British Columbia/Mary Pack Arthritis Centre, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Previous or current microscopic evidence of aortitis (active or healed) on surgical specimen obtained during aortic resection
  • 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

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

Treatment and study plan

Primary outcomes

  1. Phenotypic correlates of genotype

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2017
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.