Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04444128

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Location status: Recruiting

Location contact

Valentina O Puentmann, MD, PhD

CONTACT

[email protected]

+4969186760

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac Imaging

Diagnostic Test

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 outcomes

  1. All-cause mortality

    Time frame: 1 year

    number of deaths

  2. All-cause mortality

    Time frame: 5 years

    number of deaths

Secondary outcomes

  1. Heart Failure Outcome

    Time frame: 1 year and 5 years

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

  2. Cardiovascular Outcome

    Time frame: 1 year and 5 years

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

  3. Arrhythmia Outcome

    Time frame: 1 year and 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina O Puentmann

CONTACT

[email protected]

+4969 630184491

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Acronym: IMPReSSION

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Jun 23, 2020
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.