About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Ability to provide informed non-opposition
Referred for a CMR and/or nuclear imaging exam
Suspected Myocarditis (acute or chronic, and whatever the aetiologies)
Disqualifiers
Inability to provide non-opposition
History of heart transplant
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
observational study
Other interventionobservational study
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Baseline characteristics
Epidemiologic distribution of clinical, biological and cardiovascular imaging characteristics at baseline.
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
Proportion of patients with all-cause mortality at 1-year follow-up.
Proportion of patients with cardiovascular mortality at 1-year follow-up.
Sponsors and contacts
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