Patients who undergo echocardiography
Conditions
Interventions
None listed
Sponsors
Juntendo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 20 years or older who underwent transthoracic echocardiography in the physiological examination department of our hospital between April 1, 2023, and March 31, 2024, and who did not meet any of the exclusion criteria.
Exclusion criteria
Exclusion criteria: Patients whose echocardiographic data are unavailable or inadequate for analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients in whom cardiac amyloidosis (CA) or heart failure with preserved ejection fraction (HFpEF) is diagnosed using AI-based echocardiographic analysis software (US2.ai). Diagnosis definitions for CA: Clinical definition: CA is basically classified as transthyretin cardiac amyloidosis (ATTR-CM) or AL (amyloid light-chain) cardiac amyloidosis (AL-CM). In this study, each type is diagnosed according to the following definitions. ATTR-CM: A condition that presents clinically diagnosed ATTR amyloidosis by any of tissue biopsy, 99mTc-pyrophosphate scintigraphy, cardiac magnetic resonance imaging (MRI), and genetic testing and cardiac involvement proven by echocardiography or cardiac magnetic imaging. AL-CM: A condition that presents clinically diagnosed AL amyloidosis by M protein proven (detected by immunoelectrophoresis, immunofixation, or free light chain) in tissue biopsy, blood, or urine and cardiac involvement proven by echocardiography or cardiac magnetic imaging US2.ai definition: A condition expected to be positive by US2.ai (no differentiation between ATTR-CM and AL-CM will be made) Diagnosis definitions for HFpEF: Clinical Definition: A condition clinically diagnosed as HFpEF by the treating physician based on universal definition of heart failure and with the left ventricular ejection fraction (LVEF) >=50% as determined by conventional echocardiography and an HFA-PEF score >=5 (or >=4 if a BNP value is not available) US2.ai definition: A condition expected to be positive by US2.ai or accompanied by symptoms suggestive of heart failure and with the LVEF >=50% and an HFA-PEF score >=5 (or >=4, if a BNP value is not available) as determined by the US2.ai's analysis on echocardiography data | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome 1: Describe the number of patients clinically screened as CA/HFpEF by manual echocardiographic measurement. Secondary Outcome 2: Describe the number of patients not clinically screened as CA/HFpEF by manual echocardiographic measurement. Secondary Outcome 3: Characterize the patients screened as CA/HFpEF by Us2.ai. Secondary Outcome 4: Characterize the patients clinically screened as CA/HFpEF by manual echocardiographic measurement. Secondary Outcome 5: Characterize the patients screened as CA/HFpEF by Us2.ai but not clinically screened by manual echocardiographic measurement. Secondary Outcome 6: Determine the prevalence of CA among patients with HF and HFpEF as screened by Us2.ai. Exploratory Outcome 1: Investigation of the reasons for disagreement between AI-based and manual analysis in the diagnosis of CA or HFpEF. Exploratory Outcome 2: The number of patients diagnosed with CA or HFpEF through AI-based analysis who had received clinical treatment. Exploratory Outcome 3: Assessment of the analytical performance of US2.ai in clinical practice. | — |
Countries
Japan
Contacts
Public ContactNobuyuki Kagiyama
Juntendo University Hospital Department of Cardiovascular Biology and Medicine
Outcome results
None listed