Orienting project on crystal deposits in gout, CPPD, and osteoarthritis
The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study
This project will follow adults with gout or CPPD and people with osteoarthritis to see if crystal deposits in joints and blood vessels change over time and relate to treatments or heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT07504146 on ClinicalTrials.gov |
What this trial studies
This is a single-center, longitudinal observational project at IRCCS Galeazzi - Sant'Ambrogio Hospital enrolling consecutive outpatients with gout or CPPD and disease-controls with osteoarthritis. Participants receive routine clinical, laboratory, and imaging assessments (including ultrasound and X-rays) at baseline and every six months, with urgent visits as needed, and data are extracted from medical records. The first phase measures the extent of crystal deposits in joints and blood vessels, and the second phase monitors how deposits progress, how they associate with standard therapies, and whether they link to cardiovascular complications. Follow-up data may be collected for up to 10 years to capture long-term patterns and outcomes.
Who should consider this trial
Good fit: Adults (over 18) diagnosed with CPPD by ACR/EULAR 2023 criteria or gout by ACR/EULAR 2015 criteria, and disease-controls with OA meeting ACR criteria, who can provide informed consent, are ideal candidates.
Not a fit: People under 18, those who do not meet the specified diagnostic criteria, or those unable to attend baseline and follow-up visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors better monitor crystal deposits and tailor treatments to reduce joint damage and potential cardiovascular complications.
How similar studies have performed: Previous imaging studies have documented crystal deposits and suggested links to cardiovascular risk, but long-term comparative longitudinal data like this are limited, so the approach is partly supported yet relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria for CPPD patients are: * Patients diagnosed with CPPD disease according to the ACR/EULAR 2023 classification criteria. * Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions. * Aged older than 18 years. * Able to provide informed consent, according to requirements of local IRB/ethics committee. The inclusion criteria for gout patients are: * Patients diagnosed with gout according to the ACR/EULAR 2015 classification criteria. * Aged older than 18 years. * Able to provide informed consent, according to requirements of local IRB/ethics committee. The inclusion criteria for disease controls are: * A diagnosis of OA according to ACR classification criteria * No evidence of uric acid or calcium pyrophosphate deposits on US * Uric acid \< 6 mg/dL * Aged older than 18 years. * Able to provide informed consent, according to requirements of local IRB/ethics committee The exclusion criteria for gout/CPPD patients are: * Known history of other inflammatory arthropathies * Unable to provide informed consent, according to requirements of local IRB/ethics committee. The exclusion criteria for disease controls are: * Known history of other inflammatory arthropathies * Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Where this trial is running
Milan, Milano
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Georgios Filippou, MD — Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
- Study coordinator: Georgios Filippou, MD
- Email: georgios.filippou@grupposandonato.it
- Phone: 0039 0283502707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.