An observational study in Pericarditis, Tako-TSUBO Cardiomyopathy and Myocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 25 observational studies indexed under Pericarditis.
Browse Pericarditis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 1years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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