Prospective Longitudinal Cohort Study of Vasculitis Patients
Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage
Assistance Publique - Hôpitaux de Paris
670 participants
Jul 2, 2020
OBSERVATIONAL
Conditions
Summary
VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.
Eligibility
Inclusion Criteria6
- Adult patients (age over 18 years),
- Patients with vasculitis, as defined in the Chapel Hill International Nomenclature as revised in 2012,
- Patients included at an active phase of the disease, either the initial flare or a relapse,
- Patients who have been informed and have signed the consent
- Pregnant and breastfeeding women may be included in the study,
- Affiliated to a social security system (beneficiary or entitled person).
Exclusion Criteria8
- Refusal of consent or inability to obtain consent,
- A patient who is insane or not entitled, for psychiatric reasons or intellectual impairment, to receive information about the protocol and to give informed consent,
- Patient under guardianship / curators
- Patient on state medical assistance (AME)
- Hemoglobin less than 7 g/dl at the time of sampling,
- Hemoglobin level less than 9 g/dl at the time of sampling if the patient has respiratory or cardiovascular disease,
- Patient weighs less than 18 kg.
- Parallel participation in an interventional protocol is permitted.
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Interventions
Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse
Biological samples at M0, M6, M12, M24 and at each relapse until M60
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04413331