AortitisNCT03022331
VCRC Longitudinal Protocol for Aortitis
An observational study of Aortitis, run by University of Pennsylvania at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Aortitis
- How many people
- 16 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 4 Dec 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University
Boston, Massachusetts, 02118
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Pennsylvania
Philadelphia, Pennsylvania, 19105
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Canada3 sites
St. Joseph's Healthcare
Hamilton, Ontario, L9C 0E3
University of Toronto, Mount Sinai Hospital
Toronto, Ontario
University British Columbia/Mary Pack Arthritis Centre
Vancouver, British Columbia
About this study
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.
Read the 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.
- Conditions
- Aortitis
- Keywords
- Idiopathic aortitis, Isolated aortitis, Vasculitis
- Medical subject headings
- Aortitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start4 Dec 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AortitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Nataliya Milman, MD, MSc, Principal investigator, University of OttawaPeter A Merkel, MD, MPH, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022331
- Sponsor's protocol ID
- VCRC5507
- Other IDs
- U54AR057319
- Status last verified
- May 2020
- First submitted
- 20 Dec 2016
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCRC Longitudinal Protocol for Aortitis
- ClinicalTrials.gov ID
- NCT03022331
- Acronym / sponsor ID
- VCRC5507
- Conditions
- Aortitis
- Keywords
- Idiopathic aortitis, Isolated aortitis, Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Related InfoLink provided by the sponsor.
Related trials for Aortitis
RecruitingObservational study
China Aortic Infection and Graft Infection Study: An Ambispective Cohort
Vascular Graft Infection, Infectious Aortitis
RecruitingObservational study
VCRC Tissue Repository
Aortitis, Cutaneous Vasculitis
RecruitingObservational study
VIP - Vascular Infection Project
Aortitis, Vascular Graft Infection
RecruitingObservational study
TocILizumab in aorTitis in GCA (TILT)
Aortitis, Giant Cell Arteritis (GCA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nataliya Milman, MD, MSc principal investigator
University of Ottawa
Peter A Merkel, MD, MPH study director
University of Pennsylvania
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortitis, run by University of Pennsylvania at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic correlates of genotype (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.