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Prospective Follow-up Study of the Aortic Diameter in Patients With Giant Cell Arteritis (ATACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Daniel Blockmans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01588483
First received: April 23, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age. The disease has limited mortality, mostly due to the development of aortic aneurysms, leading to dissection and rupture. The probability to develop this complication is 17 x higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with GCA when compared with a control group. Therefore, follow-up of the aortic diameter in patients with GCA is part of good clinical practice. Previous retrospective research showed a link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta during follow-up (on computed tomography (CT)).

The purpose of this prospective study is to follow-up on the aortic diameter, and to correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to define a group of patients at high risk to develop an aortic aneurysm, already at the time of diagnosis.


Condition
Giant Cell Arteritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study for the Follow-up of Aortic Diameter in Patients With Arteritis Temporalis / Giant Cell Arteritis.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Diameter of aorta. [ Time Frame: yearly, until 10 years after diagnosis ] [ Designated as safety issue: No ]
    diameter of ascending aorta, arcus aortae, descending aorta, suprarenal, juxtarenal and infrarenal abdominal aorta

  • Volume of aorta [ Time Frame: yearly, until 10 years after diagnosis ] [ Designated as safety issue: No ]
    volume of the thoracic and abdominal aorta


Estimated Enrollment: 150
Study Start Date: March 2012
Groups/Cohorts
giant cell arteritis
patients with biopsy and/or scintigraphy proven GCA

Detailed Description:

As standard care, all patients with a suspicion of GCA undergo a biopsy of the temporal artery and a PET scintigraphy to evaluate the presence of large vessel vasculitis. Patients with proven GCA on biopsy and/or scintigraphy undergo a computed tomography (CT) of the aorta without the administration of contrast, at diagnosis and yearly thereafter (every 12 +/- 3 months) for 10 years.

Measurements include the diameter of the ascending aorta, aortic arch, descending aorta, suprarenal, juxtarenal and infrarenal aorta, and the volume of the thoracic and the abdominal aorta. These measurements are correlated with FDG-uptake at the level of the aorta on PET-scintigraphy at the time of diagnosis. All patients will be treated according to accepted guidelines and standard care in our center (methylprednisolone started at 32 mg/day, with slowly declining doses until stop after 1 to 1,5 years of treatment).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Proven Giant Cell Arteritis

Criteria

Inclusion Criteria:

  • patients with a first episode of biopsy and/or scintigraphy proven giant cell arteritis
  • patients with a previous diagnosis of giant cell arteritis, in whom a yearly computed tomography of the aorta is available can opt to participate in this study
  • informed consent form has to be signed by all patients

Exclusion Criteria:

  • patients already treated with steroids before performance of PET-scintigraphy
  • earlier episodes of giant cell arteritis, without documentation of the aortic diameter at that moment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588483

Contacts
Contact: Daniël Blockmans, MD, PhD daniël.blockmans@uzleuven.be
Contact: Liesbet Henckaerts, MD, PhD liesbet.henckaerts@uzleuven.be

Locations
Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Daniël Blockmans, MD, PhD       daniel.blockmans@uzleuven.be   
Contact: Liesbet Henckaerts, MD, PhD       liesbet.henckaerts@uzleuven.be   
Principal Investigator: Daniël Blockmans, MD, PhD         
Sub-Investigator: Liesbet Henckaerts, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Daniël Blockmans, MD, PhD University Hospital, Gasthuisberg
  More Information

Publications:
Responsible Party: Dr. Daniel Blockmans, prof. dr. Daniël Blockmans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01588483     History of Changes
Other Study ID Numbers: ATACT-study
Study First Received: April 23, 2012
Last Updated: April 26, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Giant Cell Arteritis
Arteritis
Polymyalgia Rheumatica
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Connective Tissue Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Vascular
Vascular Diseases
Vasculitis
Vasculitis, Central Nervous System

ClinicalTrials.gov processed this record on November 20, 2014