INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH

NCT07737470 | Not Yet Recruiting

• 1 other identifier: APHP251269
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inflammatory Cardiovascular Diseases

Keywords

Inflammatory cardiovascular diseases (ICARDs); Autoimmune rheumatic diseases; Cardiovascular involvement; Immunophenotyping; roteomics; Biomarkers; Biobanking; Major adverse cardiovascular events (MACE); Cardiovascular imaging; Prospective observational study

Outcome Measures

Primary Outcomes (1)

• 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.

  1years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \. Patient enrolled in EACVI-INFLAME study 2. The patient consents

You may not qualify if:

• \. Patients with a history of heart transplant 2. Patient unable to provide informed consent 3. Patient under complete or limited guardianship 4. Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (5 mL citrate tube) collected during routine clinical blood draws for plasma, peripheral blood mononuclear cell (PBMC), immunophenotyping, and proteomic analyses; optional 12-month follow-up blood samples.

Central Study Contacts

Théo PEZEL, PH

CONTACT

+33 6 68 72 24 89; theo.pezel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07