University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Location status: Recruiting
NCT Number: NCT04444128
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Frankfurt am Main, Hesse, Germany
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 year
number of deaths
Time frame: 5 years
number of deaths
Time frame: 1 year and 5 years
Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure
Time frame: 1 year and 5 years
Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)
Time frame: 1 year and 5 years
Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT
Contact information is provided by the study sponsor or research team.
Johann Wolfgang Goethe University Hospital
Other
Acronym: IMPReSSION
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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