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RECRUITING
NCT04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Sponsor: Johann Wolfgang Goethe University Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6000

Start Date

2016-11-15

Completion Date

2030-06-30

Last Updated

2026-01-06

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Cardiac 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.

Locations (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany