To evaluate anti-inflammatory effects of statin therapy on vessel wall inflammation by means of FDG PET/CT in AS patients.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Effect of 3 months statin therapy on vessel wall FDG uptake.
Secondary outcome
- Medical history, medication use, prior use of DMARD*s and biologicals
- Demographic parameters (age, race, gender)
- Cardiovascular risk factors
- Inflammatory parameters: CRP, hsCRP, BSE, IL1, Il6, TNF, IL17
Background summary
Ankylosing Spondylitis (AS) is a systemic inflammatory disease characterized by
axial joint involvement, sacroiliitis and various extra-articular
manifestations. It has been suggested that atherogenesis may be enhanced in AS.
The inflammatory process in the vessel wall, comprising atherosclerosis, may be
amplified by the presence of a systemic inflammation state in AS. In line with
other patients with increased cardiovascular risk, AS patients may benefit from
statin therapy by virtue of reduced vessel wall inflammation, thereby also
decreasing their risk of cardiovascular events.
Study objective
To evaluate anti-inflammatory effects of statin therapy on vessel wall
inflammation by means of FDG PET/CT in AS patients.
Study design
This is a multi-centre intervention study. At baseline a PET/CT will be
performed. All AS patients will be enrolled and treated for 3 months with
statin therapy, after which PET/CT will be repeated.
Intervention
All AS patients will receive statin therapy after baseline imaging. Statin
therapy will consist of a once daily dose of 40 mg Atorvastatin.
Study burden and risks
The study consists of 2 study visit and 3 scheduled telephonic appointments.
Patients will undergo 2x FDG PET/CT scan (2 hour) and 2x venapuncture will be
performed to withdraw (25 ml blood for every visit, 50ml for total study
duration).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Subjects with AS
- Age: *18 years
- Diagnosis of AS (following the 1984 Modified New York Criteria for ankylosing Spondylitis (16)) + disease duration since start of first symptoms for a period of more than 3 years.
Exclusion criteria
Subjects may not enter this study if they meet the following criteria
-BMI > 30.
-history of diabetes mellitus/insulin use
-hypertension/use of blood pressure lowering medication
-use of statins or contraindications for the use of statins
-history of cardiovascular events
-proven or suspected bacterial infections.
-use of anti-inflammatory medication from group "biologicals"
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002860-19-NL |
| CCMO | NL45456.018.13 |