An observational study in Myocarditis, ANCA Associated Vasculitis and Pericarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 208 across 120 observational studies indexed under Myocarditis.
Browse Myocarditis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
all patients with a suspicion of cardiovascular involvement due to a suspected or previously diagnosed ICARD referred for a CMR and/or nuclear imaging exam.
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.
AND a suspicion of one of the following ICARDs :
Suspected Connective tissue disease with cardiovascular involvement:
Suspected Vasculitis with cardiovascular involvement:
Suspected Inflammatory disease with cardiovascular involvement:
Exclusion Criteria:
observational study
Proportion of patients with confirmed cardiovascular involvement among consecutive patients with a suspicion of cardiovascular involvement due to a suspected or known ICARD referred for CMR and/or nuclear imaging exam.
To assess the proportion of patients with confirmed cardiovascular involvement among consecutive patients with suspected or known ICARD referred for CMR and/or nuclear imaging exam in a multicentre international and prospective study.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Baseline characteristics
Epidemiologic distribution of clinical, biological and cardiovascular imaging characteristics at baseline.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients presenting with the clinical composite outcome at 1year follow-up
Proportion of patients presenting with the clinical composite outcome at 1year follow-up defined as the proportion of patients presenting with: * Cardiovascular mortality and/or * Hospitalization for heart failure (HF) and/or * Myocardial infarction and/or * Incident atrial fibrillation and/or * Stroke and/or * Recurrence of ICARD
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients with all-cause mortality at 1-year follow-up.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients with cardiovascular mortality at 1-year follow-up.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients hospitalized for heart failure at 1-year follow-up.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients hospitalized for an acute episode of ICARD at 1-year follow-up.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of patients achieving the remission of ICARD at 1-year follow-up.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Proportion of participants for whom cardiac imaging led to a guideline-concordant diagnosis, according to the cardio-rheumatology team, and specific to each ICARD category.
Time frame: At each diagnostic assessment point, up to study completion, an average of 1 year.
Started Nov 2025 (actual). Primary completion is estimated for Aug 2027, 21 months after the start.
Of 70 non-industry observational studies under Myocarditis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 251. This study's planned 21 months is below that.
Counting every sponsor, half of 71 studies reached it within 69 months; a quarter within 20 and three quarters within 251.
How these figures are worked out, and which studies are left out of them.
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