RecruitingNCT04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Sponsor

Johann Wolfgang Goethe University Hospital

Enrollment

6,000 participants

Start Date

Nov 15, 2016

Study Type

OBSERVATIONAL

Conditions

Heart Failure Long COVID Syndrome Myocarditis Myocardial Fibrosis Vascular Inflammation

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Able to provide informed consent
years of age and over
Absence of a valid clinical indication for CMR, and/or known or clinically relevant cardiac disease

Exclusion Criteria1

accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)

Interventions

DIAGNOSTIC_TESTCardiac Imaging

Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography, blood sampling and cardiopulmonary exercise testing.