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NCT Number: NCT07586137

SysteMic vAsculitis pRognosis and ouTcome

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Reumatologia

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Carlomaurizio Montecucco, MD

CONTACT

[email protected]

+390382502948

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 10 years

  2. vasculitis complications

    Time frame: 10 years

  3. rate of relapse

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Carlomaurizio Montecucco, MD

CONTACT

[email protected]

+390382502948

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: SMART

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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