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 prospective observational study collects imaging and clinical data from people with suspected or known inflammatory cardiovascular disease or autoimmune rheumatic disease who are referred for CMR and/or cardiac PET. It measures how often cardiovascular involvement is confirmed and records clinical outcomes. Follow-up and diagnostic assessments occur with about one year of outcome tracking.
What it is studying. Whether multimodality cardiovascular imaging (CMR, cardiac PET, and echocardiography) identifies and characterizes confirmed cardiovascular involvement in people with suspected or known inflammatory cardiovascular or autoimmune rheumatic diseases, and how imaging findings relate to clinical outcomes.
What the researchers hope to learn. To estimate how often cardiovascular involvement is confirmed in this population; describe baseline clinical and imaging features; measure 1-year clinical outcomes; assess how imaging contributes to guideline-concordant diagnoses across ICARD categories; and collect real-life data on treatments, drug tapering, and cases unresponsive to therapy to inform future research and guidelines.
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.
Participants undergo cardiovascular imaging as part of the study visit(s), typically a cardiovascular magnetic resonance (CMR) scan and/or a cardiac nuclear imaging exam (PET); some patients may also have transthoracic echocardiography. The study team will collect clinical information and imaging findings at the time of the diagnostic assessment. Participants are followed for about one year to record outcomes such as hospitalizations, heart-related events, recurrence of the inflammatory cardiovascular disease, and survival. This is an observational study — no treatments are assigned by the study; it records how imaging and clinical data relate to diagnosis and later outcomes.
How the study is structured. A prospective observational cohort study. People referred for CMR and/or cardiac PET (and commonly transthoracic echocardiography) have their imaging and clinical information collected at diagnostic assessment. The study determines the proportion with confirmed cardiovascular involvement and follows participants for about one year to record predefined clinical outcomes (for example death, heart-failure hospitalization, myocardial infarction, atrial fibrillation, stroke, or recurrence of disease).
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 familial Mediterranean fever
This trial is also listed on this site under adult-onset Still's disease and Behçet's disease.
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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