The study aims to test the diagnostic accuracy of native T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that native T1 mapping with a cut-off value of 1341ms (3 tesla CMR) in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA). As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking. Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, native T1 imaging provides a promising non-invasive method to identify CA. A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p\<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%. The investigators aim to test the diagnostic accuracy of native T1 mapping with the threshold of 1341ms for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
112
Observed method
Observed method
Reference method
Reference method
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
University of Leipzig
Leipzig, Saxony, Germany
Diagnostic accuracy of native T1 LV mapping for diagnosis of CA
Comparison native T1 CMR with the reference method for diagnosis of CA
Time frame: up to 7 days
Diagnostic accuracy of ATTR probability estimator to predict CA
Comparison of a probability score to predict ATTR with the final diagnosis of ATTR
Time frame: up to 7 days
Association of native T1 values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Time frame: 1 years
Association of ATTR probability estimator values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.