Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research (INFLAME-BANK)

November 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Inflammatory and Immune-mediated Diseases Biobanking for Immunophenotyping and Cardiovascular Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up.
Time Frame: 1years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP251269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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