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Recruiting NCT04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

— Observational Myocarditis Heart Failure Myocardial Fibrosis Vascular Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac Imaging.
Who it may be relevant to
Registry conditions: Myocarditis, Heart Failure, Myocardial Fibrosis, Vascular Inflammation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Diagnostic test Cardiac Imaging
    Subjects 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.

Primary outcome measures

  • All-cause mortality [Time frame: 1 year]
  • All-cause mortality [Time frame: 5 years]
Secondary outcome measures (3)
  • Heart Failure Outcome [Time frame: 1 year and 5 years]
  • Cardiovascular Outcome [Time frame: 1 year and 5 years]
  • Arrhythmia Outcome [Time frame: 1 year and 5 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Hospital Frankfurt — Frankfurt am Main

Publications

  • Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557. PMID 32730619
  • Puntmann VO, Martin S, Shchendrygina A, Hoffmann J, Ka MM, Giokoglu E, Vanchin B, Holm N, Karyou A, Laux GS, Arendt C, De Leuw P, Zacharowski K, Khodamoradi Y, Vehreschild MJGT, Rohde G, Zeiher AM, Vogl TJ, Schwenke C, Nagel E. Long-term cardiac pathology in individuals with mild initial COVID-19 illness. Nat Med. 2022 Oct;28(10):2117-2123. doi: 10.1038/s41591-022-02000-0. Epub 2022 Sep 5. PMID 36064600
  • Shchendrygina A, Ka MM, Rodriguez C, Alsoufi S, Hoffmann J, Kumar P, Carerj ML, Vanchin B, Holm N, Karyou A, Ganbat M, Nagel E, Puntmann VO. Subclinical patterns of cardiac involvement by transthoracic echocardiography in individuals with mild initial COVID-19. Sci Rep. 2025 Jan 30;15(1):3772. doi: 10.1038/s41598-025-85221-w. PMID 39885199

Identifiers

NCT: NCT04444128 · IMPReSSION Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗