Heart Failure, Long COVID Syndrome, Myocardial Fibrosis, Myocarditis, Vascular Inflammation
Conditions
Keywords
Inflammation, Remodeling, vascular inflammation
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).
Interventions
DIAGNOSTIC_TESTCardiac Imaging
Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg; mapping, volumes, function, strain and LGE); transthoracic echocardiography, blood sampling and cardiopulmonary exercise testing.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 1 year | number of deaths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactValentina O Puentmann
Outcome results
None listed