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VCRC Longitudinal Protocol for Aortitis

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ClinicalTrials.gov Identifier: NCT03022331
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases Research (ORDR)
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania

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.

Condition or disease
Aortitis

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VCRC Longitudinal Protocol for Aortitis
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Group/Cohort
Observational



Primary Outcome Measures :
  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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022331


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19105
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Canada, British Columbia
University British Columbia/Mary Pack Arthritis Centre
Vancouver, British Columbia, Canada
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L9C 0E3
University of Toronto, Mount Sinai Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Pennsylvania
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases Research (ORDR)
Investigators
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Principal Investigator: Nataliya Milman, MD, MSc University of Ottawa
Study Director: Peter A Merkel, MD, MPH University of Pennsylvania

Additional Information:
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Responsible Party: Peter Merkel, Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03022331     History of Changes
Other Study ID Numbers: VCRC5507
U54AR057319 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Keywords provided by Peter Merkel, University of Pennsylvania:
Idiopathic aortitis
Isolated aortitis
Vasculitis
Additional relevant MeSH terms:
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Aortitis
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis