Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07737470
Status
Not Yet Recruiting

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Conditions

  • ANCA-associated Vasculitis
  • Antiphospholipid Syndrome
  • Behçet Disease
  • Giant Cell Arteritis
  • Idiopathic Inflammatory Myopathies
  • Inflammatory Cardiomyopathies
  • Lupus
  • Myocarditis
  • Pericarditis
  • Rheumatoid Arthritis
  • Spondyloarthritis
  • Still Disease
  • Systemic Sclerosis
  • Takayasu Arteritis
  • Tako-TSUBO Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up. [ Time Frame: 1years ]

Central Contacts

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