About this trial
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).
The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis.
The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes.
The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient enrolled in EACVI-INFLAME study
The patient consents
Disqualifiers
Patients with a history of heart transplant
Patient unable to provide informed consent
Patient under complete or limited guardianship
Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)
Trial population
Adults enrolled in the EACVI-INFLAME study with suspected or previously diagnosed inflammatory cardiovascular diseases (ICARDs) referred for cardiovascular magnetic resonance (CMR) and/or nuclear imaging, who provide informed consent.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up.
Occurrence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, incidental atrial fibrillation, stroke, and recurrent ICARD, assessed at 1 year after inclusion.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: