IMPReSSION: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04444128
• Collaborator: Kerckhoff Klinik (Other), Johannes Gutenberg University Mainz (Other), University Hospital Ulm (Other)
• Enrollment: 3,000
• Locations: 3
• Anticipated Duration (Months): 120
• Patients Per Site: 1000
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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, 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).

Condition or Disease	Intervention/Treatment	Phase
Myocarditis; Heart Failure; Myocardial Fibrosis; Vascular Inflammation	Diagnostic Test: Cardiac Imaging

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
• Actual Study Start Date: Nov 15, 2016
• Anticipated Primary Completion Date: Nov 15, 2022
• Anticipated Study Completion Date: Nov 15, 2026

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [1 year]

   number of deaths

2. All-cause mortality [5 years]

   number of deaths

Secondary Outcome Measures

1. Heart Failure Outcome [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 [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 [1 year and 5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kerckhoff Hospital	Bad Nauheim	Hessen	Germany	61231
2	University Hospital Frankfurt	Frankfurt	Hessen	Germany	Frankfurt am Main
3	University Hospital Mainz	Mainz	Hessen	Germany	55131

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital
• Kerckhoff Klinik
• Johannes Gutenberg University Mainz
• University Hospital Ulm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• 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: Jun 23, 2020
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Valentina Puentmann, Priv Doz Dr Dr, Johann Wolfgang Goethe University Hospital: Inflammation; Remodeling
• Additional relevant MeSH terms: Myocarditis; Inflammation

Study Results

No Results Posted as of Jun 2, 2022