IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Recruiting · NCT04444128 · Observational (researchers observe without assigning treatment) · Lead sponsor: Johann Wolfgang Goethe University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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)
Where it is running
1 location listed.
- University Hospital Frankfurt - Frankfurt am Main, Hesse, Germany