The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Extent of CPP crystal deposition assessed by ultrasound over time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Extent of CPP crystal deposition assessed by ultrasound over time
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- ESR(From baseline every 6 months up to 10 years)
- CRP(From baseline every 6 months up to ten years)
- Synovitis Score Assessed by Global OMERACT-EULAR Synovitis Score (GLOESS)(Baseline and every 6 months up to 10 years)
- Tenosynovitis Score Assessed by OMERACT Ultrasound Scoring System(Baseline and every 6 months up to 10 years)
- Joint Effusion Score Assessed by Ultrasound(Baseline and every 6 months up to 10 years)
- Number of Tender Joints Assessed Using 68-Joint Count(Baseline and every 6 months up to 10 years)
- Number of Swollen Joints Assessed Using 66-Joint Count(Baseline and every 6 months up to 10 years)
- Physician Global Assessment of Disease Activity(Baseline and every 6 months up to 10 years)
- Patient Global Assessment of Disease Activity(Baseline and every 6 months up to 10 years)
- Patient-Reported Pain Assessed by Visual Analog Scale (VAS)(Baseline and every 6 months up to 10 years)
- Patient-Reported Global Health Status(Baseline and every 6 months up to 10 years)
- Functional Disability Assessed by Health Assessment Questionnaire (HAQ)(From baseline every six months up to ten years)
- Cardiovascular Risk Assessed by SCORE2 and SCORE2-OP(At baseline and if clinically indicated during follow-up up to ten years)
- Incidence of Cardiovascular Events(During the 10 years follow up)
- Distribution of Clinical Phenotypes of CPPD and Gout(Baseline)