IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Study Overview
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Brief Summary
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Magnetic properties of myocardial tissue change in the presence of disease. This is detectable in the change of rate of magnetic relaxation, and measurable by T1 and T2 mapping using cardiovascular magnetic resonance (CMR). These markers provide novel quantifiable imaging measures for myocardial tissue characterisation. Despite similar principles, the measurements differ considerably between different sequences, vendors and field strengths, yielding a necessity to establish robust sequence-specific normal ranges, diagnostic accuracy, relationships with clinical characteristics, cardiovascular risk factors, routine cardiac imaging parameters, and prognosis. A further unknown relates to separation between healthy myocardium and subclinical disease in subgroups of patients with suspected cardiac involvement. Examples include patients with possible inflammation, such as in patients with a recent COVID-19 infection or vaccination. Anticipated recruitment of a total of 3000 subjects, with 1500 subjects per field strength (1.5 and 3.0 Tesla).

Official Title
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IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Conditions
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Myocarditis, Heart Failure, Myocardial Fibrosis, Vascular Inflammation

Intervention / Treatment
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* Diagnostic Test: Cardiac Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent 18 years of age and over Absence of a valid clinical indication for CMR, and/or known or clinically relevant cardiac disease Exclusion Criteria: accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Cardiac Imaging|Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography and blood testing.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | number of deaths | 1 year | 
| All-cause mortality | number of deaths | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Outcome | Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure | 1 year and 5 years | 
| Cardiovascular Outcome | Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke) | 1 year and 5 years | 
| Arrhythmia Outcome | Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT | 1 year and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Remodeling