ClinicalTrials.gov record NCT07077304
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
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.
This is a prospective observational study collecting data on people with suspected or established inflammatory cardiovascular diseases (ICARDs) who are referred for cardiovascular magnetic resonance (CMR), cardiac PET, and related imaging. The study aims to find how often imaging shows confirmed heart involvement and to describe patients' baseline features and one-year outcomes. It also records whether imaging led to guideline-concordant diagnoses.
What it is studying. The study is testing how frequently multimodality cardiac imaging (CMR, PET and related exams) confirms cardiovascular involvement in people with suspected or known ICARDs, and it aims to describe diagnostic findings, baseline characteristics, and clinical outcomes over about one year.
What the researchers hope to learn. Determine the proportion of patients with confirmed cardiovascular involvement among those referred for CMR and/or cardiac PET. Describe baseline clinical and imaging characteristics. Measure one-year clinical outcomes (including mortality, heart-failure hospitalization, myocardial infarction, atrial fibrillation, stroke, and ICARD recurrence). Assess how often imaging led to a guideline-concordant diagnosis for each ICARD category.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms. Diagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights. Given the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and/or cardiac PET in a multicentric international cohort.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- observational study
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age ≥ 18 years
- Ability to provide informed non-opposition
- Referred for a CMR and/or nuclear imaging exam
- AND a suspicion of one of the following ICARDs :
- Suspected Myocarditis (acute or chronic, and whatever the aetiologies)
- Suspected Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA)
- Suspected Tako-Tsubo
- Suspected Pericarditis (acute or chronic, and whatever the aetiologies)
- Suspected Connective tissue disease with cardiovascular involvement:
- Systemic sclerosis
- Systemic lupus erythematosus
- Antiphospholipid syndrome
- Idiopathic inflammatory myopathies
- Rheumatoid arthritis, spondylarthritis
- Suspected Vasculitis with cardiovascular involvement:
- Small-vessel vasculitis (ANCA…)
- Large vessel vasculitis (Behcet disease, Takayasu…)
- Suspected Inflammatory disease with cardiovascular involvement:
- Sarcoidosis
- Still disease
Exclusion criteria
- Inability to provide non-opposition
- History of heart transplant
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic diseases (ICARDs) encompass the cardiovascular manifestations of connective tissue diseases and vasculitis, along with primary inflammation affecting all layers of the heart - such as myocarditis, pericarditis and Tako-Tsubo. ICARDs can result in a vast array of clinical cardiovascular manifestations, including coronary artery disease, acute heart failure, ventricular and supra-ventricular arrhythmia. Autoimmune rheumatic disease have been identified as independent risk factors of major cardiovascular events, even after adjusting for traditional cardiovascular risk factors, and accumulated evidence shows increased cardiovascular morbidity and mortality in ICARDs compared to the general population. Various pathophysiological mechanisms have been proposed to explain the increased risk of cardiovascular events. Suspected mechanisms include prolonged systemic inflammation, accelerated atherosclerosis, autoantibody and immune complex formation, as well as an increase in sympathetic tone which may contribute to heart failure and arrhythmia. Cardiovascular involvement in patients with ICARDs represents a diagnostic challenge due to the heterogeneity in their clinical presentation, and establishing prognosis following cardiovascular involvement is equally difficult. Multimodality cardiovascular imaging, including cardiovascular magnetic resonance (CMR), transthoracic echocardiography and positron emission tomography (PET) nuclear imaging have emerged as useful diagnostic tools to help differentiate inflammatory diseases among themselves and from other diseases, and identify prognostic markers. Multimodality cardiovascular imaging has the potential to play a major role in assessing the extent of cardiovascular involvement of both primary inflammatory cardiomyopathies and autoimmune rheumatic diseases, by allowing for an early and more accurate diagnosis, phenotypic classification and monitoring. The additive value of cardiovascular imaging, notably MRI, cardiac PET scan, and multimodality imaging in connective tissue disease and vasculitis remains unclear and has been mentioned as a research topic of interest. Moreover, this study will help acquire data on drug tapering, treatment modalities adapted to different etiologies, as well as data on ICARDs unresponsive to treatment. A thorough assessment of the current practices, diagnostic and prognostic value of multimodality imaging in the context of ICARDs has the potential to help shape future guidelines for early assessment of cardiovascular involvement in ICARDs, and potentially change treatment algorithms. The establishment of this study is particularly pertinent with the forthcoming ESC guidelines on the management of inflammatory cardiomyopathies, as it will provide real-life data on the application of these guidelines. Due to the lack of evidence in the literature on the topic of the diagnostic and prognostic value of multimodality imaging in the context of ICARDs, this "EACVI-INFLAME" international study will aim to determine the proportion of patients with confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and/or cardiac PET in a multicentric international cohort.
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.
Participate in the study's data collection when you undergo the imaging your doctors order — typically cardiovascular magnetic resonance (CMR) and/or cardiac PET; results of standard heart ultrasound may also be recorded. The study team will collect clinical information, basic laboratory and imaging data, and record treatments (including drug tapering or cases unresponsive to treatment), then follow health outcomes for about one year. This is an observational study: care and tests are those decided by your clinical team and the study records and analyzes the information from those exams.
How the study is structured. A prospective, observational cohort study. People referred for CMR and/or cardiac PET have their imaging and clinical data collected and are followed for clinical outcomes (about one year on average). No experimental treatment is assigned.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Myocarditis; ANCA Associated Vasculitis; Pericarditis; Systemic Sclerosis; Systemic Lupus Erythematosus; Idiopathic Inflammatory Myopathies; Rheumatoid Arthritis; Spondylarthritis; Behcet Disease; Takayasu Arteritis; Sarcoidosis; Still Disease; Tako Tsubo Cardiomyopathy. Does it apply to my diagnosis?
- 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 listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on adult-onset Still's disease
This trial is also listed on this site under Behçet's disease and familial Mediterranean fever.
Important dates
- Study start
- Nov 19, 2025
- Primary completion
- Aug 31, 2027 (estimated)
- Study completion
- Oct 30, 2028 (estimated)
- Target enrollment
- 5000 participants (estimated)
- Last updated on registry
- Jun 5, 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
Participating sites (1)
- Assistance Publique Hôpitaux de Paris, Paris, île de France 75010Recruiting
Paris · France
- Théo PEZEL · 668722489 ext. +33 · theo.pezel@aphp.fr
Terms used on this page · explanations by MedicalUpdates.ai
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- positron emission tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- 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.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
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 site; 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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