SysteMic vAsculitis pRognosis and ouTcome

NCT07586137 | Recruiting DMC

• 1 other identifier: SMART
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1."Theme 1": The identification of risk factors associated with poor outcome, relapse and failure to achieve remission
2. 2."Theme 2": The assessment of different tools to assess risk factors (imaging, biomarkers, clinical features)
3. 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.

Conditions

Vasculitis

Outcome Measures

Primary Outcomes (3)

• mortality

  10 years

• vasculitis complications

  10 years

• rate of relapse

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with a diagnosis of vasculitis

You may qualify if:

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

You may not qualify if:

• Inability to give informed consent

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Reumatologia

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Vasculitis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Carlomaurizio Montecucco, MD

CONTACT

+390382502948; c.montecucco@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: February 8, 2022
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

IT (1)