The Orienting Study
Recruiting · NCT07504146 · Observational (researchers observe without assigning treatment) · Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
View the official record on ClinicalTrials.gov →What this trial is about
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.
Who can take part
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 it is running
1 location listed.
- IRCCS Ospedale Galeazzi-Sant'Ambrogio - Milan, Milano, Italy