VCRC Longitudinal Protocol for Aortitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03022331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nataliya Milman, MD, MScPeter A Merkel, MD, MPH
Principal Investigator Affiliation University of OttawaUniversity of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Aortitis
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Jackie Stratton

[email protected]

78132145677

Boston University, Boston, Massachusetts

Status

Completed

Address

Boston University

Boston, Massachusetts, 02118

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Sam Hughes

[email protected]

78132145677

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Elizabeth Kisela

[email protected]

78132145677

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19105

Site Contact

B.Minal Hatwar

[email protected]

78132145677

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260

Site Contact

Laurie Hope

[email protected]

78132145677

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84112

Site Contact

Jessica Gonzalez

[email protected]

78132145677

International Sites

Vancouver, British Columbia, Canada

Status

Recruiting

Address

University British Columbia/Mary Pack Arthritis Centre

Vancouver, British Columbia,

Site Contact

Liliana Cartegena

[email protected]

78132145677

St. Joseph's Healthcare, Hamilton, Ontario, Canada

Status

Recruiting

Address

St. Joseph's Healthcare

Hamilton, Ontario, L9C 0E3

Site Contact

Sandra Messier

[email protected]

78132145677

Toronto, Ontario, Canada

Status

Recruiting

Address

University of Toronto, Mount Sinai Hospital

Toronto, Ontario,

Site Contact

Judy Vendramini

[email protected]

78132145677