Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General Population

Led by Johann Wolfgang Goethe University Hospital · Updated on 2026-01-06

6000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying changes in the magnetic properties of heart muscle tissue caused by disease, which can be detected using T1 and T2 mapping with cardiovascular magnetic resonance (CMR). This research aims to establish reliable normal ranges and diagnostic accuracy for these imaging methods across different CMR sequences, vendors, and magnetic field strengths. The study also explores how these measurements relate to clinical factors and cardiovascular risks, including in patients with suspected heart inflammation such as those recently affected by COVID-19 infection or vaccination. Participants will undergo a detailed cardiovascular imaging process including CMR with a contrast agent (gadobutrol 0.1 mmol/kg) to assess tissue mapping, heart volumes, function, strain, and late gadolinium enhancement (LGE). Additional assessments include transthoracic echocardiography, blood tests, and cardiopulmonary exercise testing. The study plans to recruit about 3000 subjects, with equal numbers scanned at 1.5 and 3.0 Tesla magnetic field strengths. During the study, participants will be monitored for outcomes such as all-cause mortality at 1 and 5 years, as well as heart failure, cardiovascular, and arrhythmia events over the same periods. The research includes healthy volunteers and those with suspected subclinical heart disease. The findings aim to improve cardiovascular risk assessment using advanced imaging techniques, with long-term follow-up extending to 5 years or more.

CONDITIONS

Brief Title

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • 18 years of age and over
  • No valid clinical indication for CMR and no known or clinically relevant cardiac disease
Not Eligible

You will not qualify if you...

  • Accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo cardiac imaging including CMR study with contrast agent, transthoracic echocardiography, blood sampling, and cardiopulmonary exercise testing.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for cardiovascular outcomes such as mortality, heart failure, cardiovascular events, and arrhythmia over several years.

Visits as needed for outcome assessment

Trial Site Locations

Total: 1 location

1

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany, Frankfurt am Main

Actively Recruiting

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Research Team

V

Valentina O Puentmann

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19).

Valentina O Puntmann, M Ludovica Carerj, Imke Wieters...

https://pubmed.ncbi.nlm.nih.gov/32730619

Subclinical patterns of cardiac involvement by transthoracic echocardiography in individuals with mild initial COVID-19.

Anastasia Shchendrygina, Mame Madjiguène Ka, Carlos Rodriguez...

https://pubmed.ncbi.nlm.nih.gov/39885199