Improving cardiovascular risk stratification with T1 mapping in the general population
Official title: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Run by Johann Wolfgang Goethe University Hospital · NCT04444128 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Johann Wolfgang Goethe University Hospital Academic / other |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Status | Recruiting |
| Started | November 15, 2016 |
| Main results expected | June 30, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT04444128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gallium-68 FAPI PET/CT to find cardiac fibrosis in heart failure
This test will use a Gallium-68 FAPI PET/CT scan to see if it can detect active heart muscle fibrosis in adults with heart failure.
-
Using Apple Watch data to predict heart failure outcomes
This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.
-
Colchicine treatment for chronic inflammatory cardiomyopathy
This study tests if colchicine can help people with chronic inflammatory cardiomyopathy who have heart issues feel better by reducing inflammation in their hearts.
-
Evaluating the safety of endocardial myocardial biopsy procedures
This study is testing the safety of a heart tissue biopsy procedure for patients with heart issues like myocarditis and cardiomyopathies to see how well it works and what risks it might have.
-
Comparing Aortix Device to Diuretics for Acute Heart Failure
This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.
-
Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS
Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.