IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Heart Failure Clinical Trial

— IMPReSSION  

Official title:

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04444128
• Other study ID #: IMPReSSION Study
• Status: Active, not recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Heart Failure
• Inflammation
• Myocardial Fibrosis
• Myocarditis
• Vascular Inflammation

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

External Links

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