RecruitingNCT07504146

The Orienting Study

The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study


Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

450 participants

Start Date

Oct 30, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria12

  • 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.
  • 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.
  • 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

Exclusion Criteria4

  • Known history of other inflammatory arthropathies
  • Unable to provide informed consent, according to requirements of local IRB/ethics committee.
  • Known history of other inflammatory arthropathies
  • Unable to provide informed consent, according to requirements of local IRB/ethics committee.

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Locations(1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milano, Italy

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NCT07504146


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