EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observational study

    Other intervention

    observational study

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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