Heart Failure Clinical Trial
— IMPReSSIONOfficial title:
IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Verified date | December 2022 |
Source | Johann Wolfgang Goethe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Germany | Kerckhoff Hospital | Bad Nauheim | Hessen |
Germany | University Hospital Frankfurt | Frankfurt | Hessen |
Germany | University Hospital Mainz | Mainz | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospital | Johannes Gutenberg University Mainz, Kerckhoff Klinik, University Hospital Ulm |
Germany,
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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