IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

Active, not recruiting

• Conditions: Heart Failure; Myocarditis; Myocardial Fibrosis; Vascular Inflammation

• Registration Number: NCT04444128
• Lead Sponsor: 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, 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	5 years	number of deaths

Secondary Outcome Measures

Name	Time	Method
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
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)
Arrhythmia Outcome	1 year and 5 years	Number of participants with documented events including sudden cardiac death, appropriate ICD discharge, sustained VT

Trial Locations

Locations (3)

Kerckhoff Hospital; 🇩🇪 Bad Nauheim, Hessen, Germany

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

University Hospital Mainz; 🇩🇪 Mainz, Hessen, Germany