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

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ClinicalTrials.gov Identifier: NCT04444128
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborators:
Kerckhoff Klinik
Johannes Gutenberg University Mainz
University Hospital Ulm
Information provided by (Responsible Party):
Valentina Puentmann, Johann Wolfgang Goethe University Hospital

Brief 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 and prognostic relationships in apparently healthy subjects with no known heart disease. A further unknown relates to separation between healthy myocardium and the subclinical disease in several groups of patients with suspected cardiac involvement. Examples include patients with systemic inflammatory conditions, as well as patients with a recent COVID-19 infection.

Condition or disease Intervention/treatment
Myocarditis Heart Failure Myocardial Fibrosis Diagnostic Test: CMR with T1 and T2 mapping

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : November 15, 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: CMR with T1 and T2 mapping
    Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg): T1 and T2 mapping, volumes, function, strain and LGE is performed.


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1 year ]
    number of deaths

  2. All-cause mortality [ Time Frame: 5 years ]
    number of deaths


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  1. Able to provide informed consent
  2. 18 years of age and over
  3. Absence of a valid clinical indication for CMR, including active cardiac symptoms 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04444128


Locations
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Germany
Kerckhoff Hospital Recruiting
Bad Nauheim, Hessen, Germany, 61231
Contact: Andreas Rolf, MD       A.Rolf@kerckhoff-klinik.de   
University Hospital Frankfurt Recruiting
Frankfurt, Hessen, Germany, Frankfurt am Main
Contact: Valentina O Puentmann, MD, PhD    +4969186760    cvi-research@kgu.de   
Contact: Franziska Weis    +4969630184454    cvi-research@kgu.de   
University Hospital Mainz Recruiting
Mainz, Hessen, Germany, 55131
Contact: Philip Wenzel, MD       wenzelp@uni-mainz.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Kerckhoff Klinik
Johannes Gutenberg University Mainz
University Hospital Ulm
Additional Information:
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Responsible Party: Valentina Puentmann, Priv Doz Dr Dr, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT04444128    
Other Study ID Numbers: IMPReSSION Study
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valentina Puentmann, Johann Wolfgang Goethe University Hospital:
Inflammation
Remodeling
Additional relevant MeSH terms:
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Myocarditis
Heart Diseases
Cardiovascular Diseases
Cardiomyopathies