IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION (IMPReSSION)

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).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Fibrosis; Heart Failure; Myocarditis; Vascular Inflammation; Long COVID Syndrome
• Intervention / Treatment: Diagnostic test: Cardiac Imaging

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Valentina O Puentmann; Phone Number: +4969 630184491; Email: cvi-studien@unimedizin-ffm.de

Study Locations

• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, Frankfurt am Main
      • Recruiting
      • University Hospital Frankfurt
      • Contact: Valentina O Puentmann, MD, PhD; Phone Number: +4969186760; Email: cvi-studien@unimedizin-ffm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	number of deaths	1 year
All-cause mortality	number of deaths	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Outcome	Number of participants with events including death due to heart failure and and hospitalisation due to Heart Failure	1 year and 5 years
Cardiovascular Outcome	Number of participants with death due to myocardial infarction, heart failure, arrhythmia or vascular events (pulmonary embolism, aortic dissection, stroke)	1 year and 5 years
Arrhythmia Outcome	Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT	1 year and 5 years

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: Johannes Gutenberg University Mainz; University Hospital Ulm; Kerckhoff Klinik

Publications and helpful links

General 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; vascular inflammation; Remodeling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Cardiomyopathies; Pathological Conditions, Signs and Symptoms; Heart Failure; Myocarditis; Inflammation
• Other Study ID Numbers: IMPReSSION Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No