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SysteMic vAsculitis pRognosis and ouTcome

SysteMic vAsculitis pRognosis and ouTcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07586137
Acronym
SMART
Enrollment
300
Registered
2026-05-14
Start date
2022-02-08
Completion date
2030-06-15
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasculitis

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. "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.

Interventions

None listed

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
mortality10 years
vasculitis complications10 years
rate of relapse10 years

Countries

Italy

Contacts

CONTACTCarlomaurizio Montecucco, MD
c.montecucco@smatteo.pv.it+390382502948

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026