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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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
01

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
03

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.

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

Exclusion Criteria:

  • accepted contraindications for a contrast-enhanced CMR study (in line with MRI safety and SmPC for contrast agent)
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • University Hospital Frankfurt
    Frankfurt am Main, Hesse Frankfurt am Main, Germany
    Recruiting
07

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

08

Registry details

Key details

Study ID
NCT04444128
Lead sponsor
Johann Wolfgang Goethe University Hospital
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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