VCRC Longitudinal Protocol for Aortitis

May 7, 2020 updated by: Peter Merkel, University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University British Columbia/Mary Pack Arthritis Centre
    • Ontario
      • Hamilton, Ontario, Canada, L9C 0E3
        • St. Joseph's Healthcare
      • Toronto, Ontario, Canada
        • University of Toronto, Mount Sinai Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19105
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

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

Investigators

  • Study Director: Peter A Merkel, MD, MPH, University of Pennsylvania
  • Principal Investigator: Nataliya Milman, MD, MSc, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2017

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCRC5507
  • U54AR057319 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe