NCT04444128 IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
| NCT ID | NCT04444128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johann Wolfgang Goethe University Hospital |
| Condition | Myocarditis |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2016-11-15 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2016-11-15 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Able to provide informed consent 2. 18 years of age and over 3. Absence of a valid clinical indication for CMR, and/or known or clinically relevant cardiac disease Exclusion Criteria: * accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04444128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04444128 currently recruiting?
Yes, NCT04444128 is actively recruiting participants. Contact the research team at cvi-studien@unimedizin-ffm.de for enrollment information.
Where is the NCT04444128 trial being conducted?
This trial is being conducted at Frankfurt am Main, Germany.
Who is sponsoring the NCT04444128 clinical trial?
NCT04444128 is sponsored by Johann Wolfgang Goethe University Hospital. The trial plans to enroll 6,000 participants.