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

NCT01588483 | Completed DMC

• 1 other identifier: ATACT-study
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (2)

• Diameter of aorta.

  diameter of ascending aorta, arcus aortae, descending aorta, suprarenal, juxtarenal and infrarenal abdominal aorta

  yearly, until 10 years after diagnosis

• Volume of aorta

  volume of the thoracic and abdominal aorta

  yearly, until 10 years after diagnosis

Study Arms (1)

giant cell arteritis

patients with biopsy and/or scintigraphy proven GCA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Proven Giant Cell Arteritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Blockmans D, Coudyzer W, Vanderschueren S, Stroobants S, Loeckx D, Heye S, De Ceuninck L, Marchal G, Bobbaers H. Relationship between fluorodeoxyglucose uptake in the large vessels and late aortic diameter in giant cell arteritis. Rheumatology (Oxford). 2008 Aug;47(8):1179-84. doi: 10.1093/rheumatology/ken119. Epub 2008 May 31.

  PMID: 18515868 BACKGROUND

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Daniël Blockmans, MD, PhD

  University Hospital, Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Daniël Blockmans

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: May 1, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

BE (1)