Image

The Orienting Study

The Orienting Study

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Description

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.

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.

Study details
    CPPD - Calcium Pyrophosphate Deposition Disease
    Gout

NCT07504146

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

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.