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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04444128
Other study ID # IMPReSSION Study
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 15, 2016
Est. completion date June 30, 2030

Study information

Verified date December 2022
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 6000
Est. completion date June 30, 2030
Est. primary completion date June 30, 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Cardiac Imaging
Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography and blood testing.

Locations

Country Name City State
Germany Kerckhoff Hospital Bad Nauheim Hessen
Germany University Hospital Frankfurt Frankfurt Hessen
Germany University Hospital Mainz Mainz Hessen

Sponsors (4)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital Johannes Gutenberg University Mainz, Kerckhoff Klinik, University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality number of deaths 1 year
Primary All-cause mortality number of deaths 5 years
Secondary 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
Secondary 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
Secondary Arrhythmia Outcome Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT 1 year and 5 years
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