NCT03022331

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

December 20, 2016

Last Update Submit

May 7, 2020

Conditions

Aortitis

Keywords

Idiopathic aortitisIsolated aortitisVasculitis

Outcome Measures

Primary Outcomes (1)

  • Phenotypic correlates of genotype

    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

Study Arms (1)

Observational

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19105, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University British Columbia/Mary Pack Arthritis Centre

Vancouver, British Columbia, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L9C 0E3, Canada

Location

University of Toronto, Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples, including genetic information (DNA), will be collected from patients with aortitis in this study.

MeSH Terms

Conditions

AortitisVasculitis

Condition Hierarchy (Ancestors)

Aortic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nataliya Milman, MD, MSc

    University of Ottawa

    PRINCIPAL INVESTIGATOR

  • Peter A Merkel, MD, MPH

    University of Pennsylvania

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Rheumatology Professor of Medicine and Epidemiology

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 16, 2017

Study Start

December 4, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

US(7)CA(3)