SysteMic vAsculitis pRognosis and ouTcome (SMART)

This will be a pragmatic programme of research, consecutively recruiting all-comers who have been referred to secondary care for assessment of suspected Systemic Vasculitis (SV) into a longitudinal inception cohort. For patients with a pre-existing diagnosis, data on the disease onset will be collected retrospectively. All patients followed prospectively from the time of inclusion into the study will be followed at intervals corresponding to the recommended standard of care. We will invite participants to consent to the whole programme of research in order to allow their samples, as well as their data, to be used for in multiple related projects that have the same common aim. In this long-term inception cohort we will collect data on clinical features, prognostic factors and outcomes of patients diagnosed with a SV over the course of 10 years. We will examine the role of clinical features, imaging and biomarkers in the characterisation of the disease with a particular focus on risk stratification. This will be closely integrated with the other objectives of the study: analysing clinical features, imaging characteristics, outcomes, rates and predictors of relapses and remission, in order to obtain a prognostic stratification of the patients and to capture a cohort of patients at high risk of relapse and poor outcome who could inform on the potential use of more intensive treatment strategies to be assessed in future studies.

The SMART programme will be guided by three main overarching themes:

1. "Theme 1": The identification of risk factors associated with poor outcome, relapse and failure to achieve remission
2. "Theme 2": The assessment of different tools to assess risk factors (imaging, biomarkers, clinical features)
3. "Theme 3": The analysis of cohorts of SV patients in observational studies The overarching aims of the study will be overlapping throughout the different investigations outlined in the following paragraphs analyzing: outcomes (including treatment-derived damage), monitoring and relapse, and remission in SV.

We aim to follow patients up over a total of 10 years, in order to provide the richest and most complete set of data that has ever been collected for this patient group.

Study Overview

• Status: Recruiting
• Conditions: Vasculitis

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Carlomaurizio Montecucco, MD; Phone Number: +390382502948; Email: c.montecucco@smatteo.pv.it

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo, SC Reumatologia
      • Contact: Carlomaurizio Montecucco, MD; Phone Number: +390382502948; Email: c.montecucco@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with a diagnosis of vasculitis

Description

Inclusion Criteria:

• Willing and able to give informed consent
• clinical suspicion or a confirmed diagnosis of Systemic Vasculitis

Exclusion Criteria:

• Inability to give informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	10 years
vasculitis complications	10 years
rate of relapse	10 years

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2030

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Vasculitis
• Other Study ID Numbers: SMART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No