ClinicalTrials.gov record NCT07737470
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
INFLAME-BANK is a prospective observational study creating a blood biobank and performing immune and proteomic analyses in people with inflammatory cardiovascular and autoimmune rheumatic diseases. About 300 adults enrolled in the EACVI-INFLAME study will give an extra 5 mL blood sample at inclusion, with optional 12‑month samples. Depending on the study center, optional procedures may include photon-counting CT (PCCT) imaging and genetic testing. Participants are followed for 12 months to record cardiovascular outcomes, including major adverse cardiovascular events (MACE). Data and samples will be analyzed to find immune biomarkers and develop disease-specific prognostic scores.
What it is studying. The study tests whether immune and proteomic measurements in blood are associated with cardiovascular outcomes and can help build disease-specific prognostic scores to predict 1‑year major adverse cardiovascular events (MACE). It also evaluates the diagnostic and prognostic value of immuno-proteomic biomarkers, the potential role of photon-counting CT (PCCT) imaging compared with other imaging, and immune signatures linked to genetic variants in acute myocarditis.
What the researchers hope to learn. Scientifically, the study aims to identify immune and proteomic biomarkers linked to cardiovascular prognosis, develop disease-specific prognostic scores for 1‑year MACE, evaluate the diagnostic and prognostic utility of immuno-proteomic markers and PCCT imaging, and investigate immune signatures associated with genetic variants in acute myocarditis. These results aim to improve understanding of immune mechanisms in inflammatory cardiovascular diseases and support earlier diagnosis, risk stratification, and development of personalized management strategies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patient enrolled in EACVI-INFLAME study
- The patient consents
Exclusion criteria
- 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)
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Detailed Description INFLAME-BANK is a French multicenter prospective observational study conducted as an ancillary project of the international EACVI-INFLAME study. Its purpose is to establish a biobank of blood samples and perform advanced immunophenotyping and proteomic analyses in patients with suspected cardiovascular involvement related to inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs). The main objective of the study is to identify immune and proteomic biomarkers associated with cardiovascular prognosis and to develop disease-specific prognostic scores capable of predicting major adverse cardiovascular events (MACE) at 1 year. The primary endpoint is the proportion of patients experiencing MACE after one year of follow-up. Secondary objectives include: Characterizing baseline immunological and proteomic profiles in patients with suspected or confirmed ICARDs. Evaluating the prognostic value of identified cellular and molecular biomarkers for individual cardiovascular outcomes, including cardiovascular death, heart failure hospitalization, ventricular arrhythmia, stroke, atrial fibrillation, recurrent ICARD, and remission. Assessing the diagnostic utility of immuno-proteomic biomarkers for detecting cardiovascular involvement in ICARD patients. Investigating the diagnostic and prognostic value of photon-counting computed tomography (PCCT) compared with other imaging modalities such as cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE). Identifying inflammation signatures associated with desmosomal genetic variants in patients with acute myocarditis. The study plans to enroll 300 patients from French centers participating in the EACVI-INFLAME protocol. Eligible participants are patients referred for CMR and/or nuclear imaging because of suspected cardiovascular involvement related to a suspected or previously diagnosed ICARD. Patients must be enrolled in the EACVI-INFLAME study and provide informed consent. At inclusion, an additional 5 mL citrate blood sample will be collected during a routine blood draw, without any additional venipuncture specifically for the study. Depending on the participating center, optional procedures may include: An additional blood sample at 12 months for plasma and/or peripheral blood mononuclear cell (PBMC) analysis. Collection and centralized analysis of PCCT imaging data, including pseudonymized DICOM images. Genetic testing by next-generation sequencing (NGS) in selected patients with acute myocarditis. Participants will be followed for 12 months, with clinical data collected from electronic health records and entered into a secure electronic case report form (CleanWeb eCRF). The study will evaluate the occurrence of MACE, defined as a composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, incidental atrial fibrillation, stroke, and recurrent ICARD. Data analyses will include conventional statistical comparisons, survival analyses, and advanced high-dimensional analyses of immune cell populations and proteomic profiles. Mass cytometry (CyTOF) and mass spectrometry data will be processed using standardized normalization, clustering, dimensionality reduction, and differential expression analysis workflows. The expected benefits of the study are substantial. INFLAME-BANK aims to improve understanding of the immune and molecular mechanisms underlying cardiovascular complications in inflammatory and autoimmune diseases, facilitate earlier diagnosis and risk stratification, support the development of personalized therapeutic strategies, and identify potential new targets for immunomodulatory or immunosuppressive treatments. The additional risks associated with participation are considered minimal, as biological samples are collected during routine clinical care and no modification of standard patient treatment is required.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you take part you give informed consent and a small additional blood sample (5 mL citrate) will be collected during a routine blood draw, so no extra venipuncture is required. Blood samples will be stored in a biobank and used for immunophenotyping and proteomic analyses. Optional procedures at some centers include an extra blood sample at 12 months, collection of photon-counting CT (PCCT) imaging data for central analysis, and genetic testing (next-generation sequencing) in selected patients with acute myocarditis. Clinical information will be followed for 12 months using electronic health records and entered into a secure database; the study does not change your usual treatment.
How the study is structured. This is a prospective observational cohort study (no experimental treatment). Participants enrolled in the EACVI-INFLAME study provide an additional 5 mL citrate blood sample during routine care at inclusion; some centers offer an optional additional blood draw at 12 months. Depending on center participation, pseudonymized PCCT imaging data may be collected and select patients with acute myocarditis may have genetic testing. Clinical data are collected from electronic health records and entered into a secure electronic case report form. Participants are followed for 12 months to assess occurrence of MACE.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
This trial is also listed on this website under adult-onset Still's disease and familial Mediterranean fever.
Important dates
- Study start
- Sep 1, 2026 (estimated)
- Primary completion
- Oct 1, 2028 (estimated)
- Study completion
- Oct 1, 2028 (estimated)
- Target enrollment
- 300 participants (estimated)
- Last updated on registry
- Aug 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Théo PEZEL, PH 📞 +33 6 68 72 24 89 ✉ theo.pezel@aphp.fr
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- biobank
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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