Clinical trial NCT04444128: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Official title: IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocarditis
Heart Failure
Myocardial Fibrosis
Vascular Inflammation
Keywords: Inflammation
Remodeling
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Kerckhoff Klinik
name: Johannes Gutenberg University Mainz
name: University Hospital Ulm
First posted: 2020-06-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are consecutive asymptomatic healthy subjects or patients from subgroups with known high risk (such as a recent COVID19 infection) with no known or clinically relevant cardiac disease or currently prescribed cardiac medication.

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).


Eligibility criteria: 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)

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Heart Failure Outcome
timeFrame: 1 year and 5 years
measure: Cardiovascular Outcome
timeFrame: 1 year and 5 years
measure: Arrhythmia Outcome
timeFrame: 1 year and 5 years
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Hospital
state: Hessen
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
city: Mainz
country: Germany
facility: University Hospital Mainz
state: Hessen
Study officials:
References:
citation: Puntmann VO, Martin S, Shchendrygina A, Hoffmann J, Ka MM, Giokoglu E, Vanchin B, Holm N, Karyou A, Laux GS, Arendt C, De Leuw P, Zacharowski K, Khodamoradi Y, Vehreschild MJGT, Rohde G, Zeiher AM, Vogl TJ, Schwenke C, Nagel E. Long-term cardiac pathology in individuals with mild initial COVID-19 illness. Nat Med. 2022 Oct;28(10):2117-2123. doi: 10.1038/s41591-022-02000-0. Epub 2022 Sep 5.
citation: Shchendrygina A, Ka MM, Rodriguez C, Alsoufi S, Hoffmann J, Kumar P, Carerj ML, Vanchin B, Holm N, Karyou A, Ganbat M, Nagel E, Puntmann VO. Subclinical patterns of cardiac involvement by transthoracic echocardiography in individuals with mild initial COVID-19. Sci Rep. 2025 Jan 30;15(1):3772. doi: 10.1038/s41598-025-85221-w.
citation: Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.