Clinical Trials in Italy / NCT07504146
Recruiting
Observational
The Orienting Study
NCT07504146 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
CPPD - Calcium Pyrophosphate Deposition DiseaseGout
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Extent of CPP crystal deposition assessed by ultrasound over time — Baseline and every 6 months up to 10 years
Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for CPPD at patient level and at joint level. Each anatomical site will be graded on a semi-quantitative scale from 0 to 3. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time. - Extent of MSU crystal deposition assessed by ultrasound over time — Baseline and every 6 months up to 10 years
Assessment of the extent of monosodium urate (MSU) crystal deposition Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for Gout Lesions (double contour sign, tophi, aggregates). Each lesion will be graded on a semi-quantitative scale from 0 to 3. A total score will be calculated by summing scores across all evaluated joints. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time. - Progression of bone erosions assessed by ultrasound — Baseline and every 6 months up to 10 years
Bone erosions will be assessed using the OMERACT Ultrasound Scoring System for Bone Erosions. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total erosion score. The measure will be assessed longitudinally to evaluate changes over time. - Progression of osteophites assessed by ultrasound — Baseline and every 6 months up to 10 years
Osteophytes will be assessed using the OMERACT Ultrasound Scoring System for Osteophytes. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total osteophyte score. The measure will be assessed longitudinally to evaluate changes over time.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Ospedale Galeazzi-Sant'Ambrogio | Milan | Milano | Recruiting |
More I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07504146 on ClinicalTrials.gov ↗ ← All trials in Italy