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Sensitive Imaging in Ankylosing Spondylitis

Sensitive Imaging in Ankylosing Spondylitis - SIAS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39151
Enrollment
40
Registered
2010-06-17
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis Bechterew disease

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a) Male and female patients of at least 18 years having Ankylosing Spondylitis (AS) fulfilling the Modified New York criteria, in which a patient has *definite* AS if the radiological criterion is associated with at least one clinical criterion: ;Clinical criterions: * low back pain and stiffness for more than 3 months that improves with exercise, but is not relieved by rest. * limitation of motion of the lumbar spine in the sagittal and frontal planes. * limitation of chest expansion relative to normal values correlated for age and sex.;Radiological criterion (sacroiliitis grade >= 2 bilaterally or grade 3-4 unilaterally) * grade 0 = no sacroiliitis * grade 1 = blurring of the joint margins (*suspicious*) * grade 2 = sclerosis, erosions, no changes in joint space * grade 3 = erosions, changes in joint space, partial ankylosis * grade 4 = complete ankylosis;b) Patients should have at least one syndesmophyte in either the cervical or lumbar spine radiograph at baseline conventional radiography. The maximum number of VUs is 9 (out of 12). ;c) The patient should have given written informed consent.

Exclusion criteria

Exclusion criteria: * > 9 by syndesmophytes affected vertebral units.;* A history of alcoholism, drug abuse, psychological or other emotional problems, severe comorbidity likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements.;* Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD, vascular clips, hearing aids and claustrophobia).;* Pregnancy.

Design outcomes

Primary

MeasureTime frame
To study whether there is a relationship between local inflammation and the development of new syndesmophytes at the same site in a vertebral unit in patients with ankylosing spondylitis: • Direct causal relationship: local inflammation * syndesmophyte formation • Indirect causal relationship: inflammation * local changes * resolved inflammation * syndesmophyte formation

Secondary

MeasureTime frame
• To examine the time order of pathologic changes (e.g. inflammation, fatty degeneration, erosion, syndesmophyte formation). • To examine the exact location of inflammation in a vertebral unit. • To test the hypothesis that syndesmophyte formation occurs at sites with complete normal anatomy without inflammation. • To assess the agreement between 3 and 7 Tesla MRI in detecting sites of inflammation • To assess the agreement between CT and conventional radiography of the cervical and lumbar spine in detecting structural changes. • To examine if the thoracic spine provides different information compared to the cervical and lumbar spine.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)