ClinicalTrials.gg
RecruitingNCT04444128IMPReSSIONUpdated Jan 6, 2026

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

An observational study in Myocarditis, Heart Failure and Myocardial Fibrosis, sponsored by Johann Wolfgang Goethe University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

From the registry’s dates

  • Started Nov 2016; still recruiting 9 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
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Study 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).

02

Conditions studied

  • Myocarditis
  • Heart Failure
  • Myocardial Fibrosis
  • Vascular Inflammation
  • Long COVID Syndrome

Keywords

  • Inflammation
  • Remodeling
  • vascular inflammation
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In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 208 across 120 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants are consecutive asymptomatic healthy subjects or patients from subgroups with known high risk (such as a recent COVID19 infection) with no known or clinically relevant cardiac disease or currently prescribed cardiac medication.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to provide
  2. 18 years of age and over
  3. Absence of a valid clinical indication for CMR, and/or known or cardiac disease

Exclusion criteria

Exclusion Criteria:

  • accepted for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testCardiac 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.

06

What researchers measure

Primary outcomes

  1. All-cause mortality

    number of deaths

    Time frame: 1 year

  2. All-cause mortality

    number of deaths

    Time frame: 5 years

Secondary outcomes

  1. Heart Failure Outcome

    Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure

    Time frame: 1 year and 5 years

  2. Cardiovascular Outcome

    Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)

    Time frame: 1 year and 5 years

  3. Arrhythmia Outcome

    Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT

    Time frame: 1 year and 5 years

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Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 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. PubMed 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. PubMed 39885199 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04444128
Responsible party
Valentina Puentmann (Priv Doz Dr Dr, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Jun 23, 2020
Start date
Nov 15, 2016
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jan 6, 2026

Study contacts

Valentina O Puentmann
Contact
cvi-studien@unimedizin-ffm.de
+4969 630184491

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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