EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases

NCT07077304 | Not Yet Recruiting

• 1 other identifier: AP-HP250504
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Cardiovascular disease; Auto-immune disease; Auto-inflammatory disease; Rheumatic disease; CMR; PET; multimodality imaging; ICARD

Outcome Measures

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.

  At each diagnostic assessment point, up to study completion, an average of 1 year.

Secondary Outcomes (8)

• Baseline characteristics

  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

  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.

  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.

  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.

  At each diagnostic assessment point, up to study completion, an average of 1 year.

Interventions

observational study OTHER

observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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:

You may not qualify if:

• Inability to provide non-opposition
• History of heart transplant

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Myocarditis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Pericarditis; Scleroderma, Systemic; Lupus Erythematosus, Systemic; Myositis; Arthritis, Rheumatoid; Spondylarthritis; Behcet Syndrome; Takayasu Arteritis; Sarcoidosis; Arthritis, Juvenile; Takotsubo Cardiomyopathy; Cardiovascular Diseases; Rheumatic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Aortic Arch Syndromes; Aortic Diseases; Arteritis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: July 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07