Improving cardiovascular risk stratification with T1 mapping in the general population
IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
This project will test whether CMR T1/T2 mapping can detect early heart inflammation or fibrosis and help predict cardiovascular risk in adults without known heart disease, including people after COVID-19 infection or vaccination.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johann Wolfgang Goethe University Hospital Academic / other |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Trial ID | NCT04444128 on ClinicalTrials.gov |
What this trial studies
This is a large observational imaging registry using cardiovascular magnetic resonance (CMR) T1 and T2 mapping to quantify myocardial tissue properties that change with disease. The study plans to enroll about 3,000 adults to establish sequence- and vendor-specific normal ranges, examine diagnostic accuracy, and link mapping values to clinical characteristics, cardiovascular risk factors, routine imaging metrics, and outcomes. Specific subgroups include people with possible myocardial inflammation such as those recently infected with or vaccinated against SARS-CoV-2 to explore separation between healthy myocardium and subclinical disease. Imaging will use standardized CMR protocols including contrast-enhanced studies where permitted, with exclusions for standard MRI/contrast contraindications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over without a current clinical indication for CMR or known cardiac disease, including people recently infected with or vaccinated against COVID-19 for the inflammation subgroup.
Not a fit: Patients with established clinically relevant cardiac disease or those with contraindications to contrast-enhanced MRI are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could enable earlier detection of subclinical myocardial inflammation or fibrosis and improve cardiovascular risk stratification.
How similar studies have performed: Prior studies have shown T1/T2 mapping can detect myocardial disease, but large-scale, sequence-specific normal ranges and cross-vendor standardization are not yet established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Frankfurt am Main, Hesse
- University Hospital Frankfurt — Frankfurt am Main, Hesse, Germany (Recruiting)
Study contacts
- Study coordinator: Valentina O Puentmann
- Email: cvi-studien@unimedizin-ffm.de
- Phone: +4969 630184491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.