IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohann Wolfgang Goethe University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
Trial population
Participants are consecutive asymptomatic healthy subjects or patients from subgroups with known high risk (such as a recent COVID19 infection) with no known or clinically relevant cardiac disease or currently prescribed cardiac medication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac Imaging
Diagnostic testSubjects 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
All-cause mortality
number of deaths
Time frame
1 year2
All-cause mortality
number of deaths
Time frame
5 yearsSecondary outcomes
1
Heart Failure Outcome
Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure
Time frame
1 year and 5 years2
Cardiovascular Outcome
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 years3
Arrhythmia Outcome
Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT
Time frame
1 year and 5 yearsSponsors and contacts
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Source ClinicalTrials.gov