NCT04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Myocarditis
• Heart Failure
• Myocardial Fibrosis
• Vascular Inflammation
• Long COVID Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-15
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2020-06-23
• Last updated: 2026-01-06

Locations

1 site across 1 country: Germany