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

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

Plain Language Summary

Simplified for easier understanding

This study is using a special type of cardiac MRI called T1 mapping to measure subtle changes in the heart muscle in people from the general population who do not have known heart disease, to see if this can predict future heart problems. **You may be eligible if...** - You are 18 or older - You do not have a known heart condition or a clinical reason to already have a cardiac MRI - You are able to give informed consent **You may NOT be eligible if...** - You have a contraindication to MRI with contrast dye (such as a pacemaker, or kidney problems that prevent use of contrast) - You have known or suspected heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

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NCT04444128


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