An observational study in CPPD - Calcium Pyrophosphate Deposition Disease and Gout, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
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.
This is a monocentric observational longitudinal study in which patients diagnosed with gout or CPPD and disease-controls with OA will be consecutively recruited from the outpatient clinics of the Rheumatology and Orthopaedic Hip Departments of the IRCCS Galeazzi - Sant'Ambrogio Hospital.
The investigators will enroll consecutive patients with CPPD and gout and disease-controls with OA fulfilling the inclusion and exclusion criteria, from the outpatient clinics of the Rheumatology Department and Orthopaedic Hip Department of the IRCCS Galeazzi - Sant'Ambrogio Hospital, who will be seen for routine or urgent gout/CPPD/OA care following local scheduling processes, without applying any further selection criteria. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory and imaging assessment, both at baseline and during scheduled follow-up visits (every 6 months) and urgent follow-up visits, tailored to each patient's needs. The study comprises two phases. The first, aims to evaluate the extent of crystal deposition in joints and in blood vessels in patients with CPPD and gout. The second, focuses on monitoring the extension of crystals deposits, their associations with conventional therapies, and evaluating the development of cardiovascular complications in patients with CPPD and gout in comparison to disease-controls with OA. The data for the study will be retrieved from the medical records of the patients and recorded into an appositely created electronic case report form (CRF). The enrollment period will last 3 years (starting from the time of approval of the study), and the follow up period will last 10 years.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 450 is above the median of 232 across 52 observational studies indexed under Gout.
Browse Gout studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by gout, CPPD or osteoarthritis.
The inclusion criteria for CPPD patients are:
The inclusion criteria for gout patients are:
The inclusion criteria for disease controls are:
The exclusion criteria for gout/CPPD patients are:
The exclusion criteria for disease controls are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by gout according to ACR/EULAR classification criteria
Patients affected by gout according to ACR/EULAR classification criteria
Patients with a diagnosis of osteoarthritis according to ACR classification criteria
Extent of CPP crystal deposition assessed by ultrasound over time
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.
Time frame: Baseline and every 6 months up to 10 years
Extent of MSU crystal deposition assessed by ultrasound over time
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.
Time frame: Baseline and every 6 months up to 10 years
Progression of bone erosions assessed by ultrasound
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.
Time frame: Baseline and every 6 months up to 10 years
Progression of osteophites assessed by ultrasound
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.
Time frame: Baseline and every 6 months up to 10 years
ESR
Change From Baseline in Erythrocyte Sedimentation Rate (ESR mm/h) between patients with CPPD and gout and disease-controls with OA
Time frame: From baseline every 6 months up to 10 years
CRP
Change From Baseline in C-Reactive Protein (CRP mg/L) between CPPD and Gout patients and controls with OA
Time frame: From baseline every 6 months up to ten years
Synovitis Score Assessed by Global OMERACT-EULAR Synovitis Score (GLOESS)
Synovitis will be evaluated thanks to Global OMERACT-EULAR Synovitis Score (GLOESS). Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Time frame: Baseline and every 6 months up to 10 years
Tenosynovitis Score Assessed by OMERACT Ultrasound Scoring System
Tenosynovitis will be assessed using the OMERACT ultrasound scoring system on a semi-quantitative scale. Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Time frame: Baseline and every 6 months up to 10 years
Joint Effusion Score Assessed by Ultrasound
Joint effusion will be assessed using ultrasound on a semi-quantitative scale from 0 to 3. The joints to be evaluated will be selected according to the clinician's judgement
Time frame: Baseline and every 6 months up to 10 years
Number of Tender Joints Assessed Using 68-Joint Count
The number of tender joints will be assessed using the 68-joint count method.
Time frame: Baseline and every 6 months up to 10 years
Number of Swollen Joints Assessed Using 66-Joint Count
The number of swollen joints will be assessed using the 66-joint count method.
Time frame: Baseline and every 6 months up to 10 years
Physician Global Assessment of Disease Activity
Disease activity will be assessed by the physician using a visual analog scale (0-100)
Time frame: Baseline and every 6 months up to 10 years
Patient Global Assessment of Disease Activity
Scale (0-100)
Time frame: Baseline and every 6 months up to 10 years
Patient-Reported Pain Assessed by Visual Analog Scale (VAS)
Scale (0-100)
Time frame: Baseline and every 6 months up to 10 years
Patient-Reported Global Health Status
Scale (0-100)
Time frame: Baseline and every 6 months up to 10 years
Functional Disability Assessed by Health Assessment Questionnaire (HAQ)
Score (0-3) for every item of the questionnaire, then the sum is calculated
Time frame: From baseline every six months up to ten years
Cardiovascular Risk Assessed by SCORE2 and SCORE2-OP
Cardiovascular risk will be estimated using SCORE2 and SCORE2-OP algorithms, depending on patient's age. Both scores express a percentage (%) of the 10-year risk.
Time frame: At baseline and if clinically indicated during follow-up up to ten years
Incidence of Cardiovascular Events
Occurrence of cardiovascular events recorded during follow-up (Number of events / % of patients)
Time frame: During the 10 years follow up
Distribution of Clinical Phenotypes of CPPD and Gout
Phenotypes of calcium pyrophosphate deposition (CPPD) disease and gout will be classified according to established classification criteria (ACR/EULAR recommendations and G-CAN consensus respectively).
Time frame: Baseline
Serum suPAR Levels Assessed by Enzyme Immunoassay
Serum soluble urokinase plasminogen activator receptor (suPAR) levels will be measured using an ELISA-based assay on blood and/or synovial fluid, whenever the patients undergo arthrocentesis for other reasons
Time frame: Once during the 10 years follow up
Intima media thickness at ultrasound of carothid arteries
Measurment of intima-media thickness (CMIT) at ultrasound of carothid arteries performed as part of routine care will be collected to assess increased atherosclerotic risk. The European Society of Cardiology (ESC) often highlights CMIT\> 0.9 as a critical threshold to determine an increased risk
Time frame: As clinically indicated during follow-up up to ten years from baseline
Assessment of joint damage using X-ray, CT or MRI
On radiographs and CT, osteoarthritis severity will be evaluated based on osteophytes, joint space narrowing, and subchondral bone changes, using a semi-quantitative grading scale (e.g., Kellgren-Lawrence grade 0-4 for radiographs). On MRI, joint damage will be assessed including cartilage integrity and other structural abnormalities using appropriate semi-quantitative scoring systems (WORMS, MOAKS)
Time frame: As clinically indicated during follow-up from baseline up to ten years
Histological and Molecular Characteristics of Joint Tissues in Patients Undergoing Arthroplasty
Biological samples (bone, cartilage, synovial membrane, ligaments/tendons, synovial fluid) collected during clinically indicated arthroplasty procedures will be analyzed using histology, immunohistochemistry, and Raman spectroscopy to assess tissue morphology, inflammatory features, and crystal deposition.
Time frame: At time of surgery (as applicable)
Coronary stenosis at Coronary Computed Tomography Angiography (CCTA)
The presence of coronary stenosis at Coronary Computed Tomography Angiography (CCTA) will be recorded. An obstructive stenosis occupies more than 50% of the lumen.
Time frame: As clinically indicated during follow up up to ten years
Assessment of bone mineral density at DEXA
Bone mineral density (BMD) will be measured using dual-energy X-ray absorptiometry at the lumbar spine and proximal femur. Results will be expressed in g/cm², T-scores, and Z-scores. Bone status will be classified as normal, osteopenia, or osteoporosis according to World Health Organization criteria.
Time frame: As clinically indicated from baseline up to ten years follow up
Evaluation of CPP crystal and MSU crystal deposition at X-ray, TC or MRI
CPP and MSU crystal deposition in articular or periarticular structures at other imaging modalities (X-rays, CT scans, MRI) will be qualitatively assessed and documented as presence/absence.
Time frame: As clinically indicated from baseline up to ten years follow up
Plan to share: Undecided
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