Artificial Intelligence in Detecting Cardiac Function
Korotkoff Sounds Dynamically Reflect Changes in Cardiac Function Based on Deep Learning Methods: A Prospective, Multicenter Study
Study Overview
Status
Conditions
Detailed Description
Blood Pressure Measurement：Around 72 hours before and after the completion of the patient's echocardiogram, considering the variability in the patient's blood pressure and ejection fraction at different times, blood pressure should be measured in each participant at least twice a day, up to a maximum of six times. Each patient should be instructed to remain in a quiet state for 10 minutes before blood pressure measurement. Blood pressure measurement should be conducted according to the following criteria: the cuff used to measure blood pressure should be wrapped around the patient's arm above the elbow joint, positioned 2-3 cm above the level of the heart, with a snugness that allows one finger to fit underneath. Place the stethoscope head at the brachial artery pulse point on the left elbow joint, then begin inflation. Inflate continuously until the sound of the pulse beat disappears; then inflate an additional 20 mmHg before stopping inflation. Slowly deflate while listening-the first audible pulse beat is the systolic pressure, and the disappearance of the pulse sound is the diastolic pressure. Use the Hanhong POPULAR-3 electronic stethoscope to record the aforementioned process, with each audio recording lasting 25 seconds uniformly.
Data Analysis Overview:
In terms of data analysis, deep learning models are developed based on Torch version 1.5.0, utilizing Transformer network architecture to analyze the collected audio data.
Network One: Identifying the presence of cardiac functional abnormalities through Korotkoff sounds.
Evaluation Metrics: Receiver Operating Characteristic (AUROC), sensitivity, specificity, and F1 score (harmonic mean of sensitivity and specificity) to assess model performance on the test dataset.
Network Two: NYHA classification of Korotkoff sounds. Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Three: Heart failure classification of Korotkoff sounds in heart failure patients.
Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Four: Left Ventricular Ejection Fraction (LVEF) prediction from Korotkoff sounds.
Evaluation Metrics: Root Mean Squared Error (RMSE), Mean Absolute Error (MAE), Mean Squared Error (MSE), R2 Score.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Zhejiang
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Yiwu, Zhejiang, China, 322000
- The Fourth Hospital Affiliated to Zhejiang University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People's Hospital, Zhejiang Quhua Hospital)between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
- Individuals aged between 18 and 90 years with a resting heart rate ranging from 60 to 100 beats per minute.
- Demonstrating good compliance, capable of cooperating in completing multiple blood pressure measurements within 72 hours following the completion of echocardiography.
- Willingness to voluntarily participate in the study.
Exclusion Criteria:
- Patients with acute decompensated heart failure, acute myocardial infarction, atrioventricular block;
- Cerebral hemorrhage, severe infection, active digestive tract ulcer, severe hematological diseases, severe liver and kidney dysfunction or other serious medical or surgical conditions;
- Pregnant or lactating women;
- Patients with mental illness;
- Individuals who have participated in other clinical trials within the past 3 months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Heart Failure
Patients with stable heart failure were defined as those with structural heart disease and a history of heart failure episodes but no current symptoms or signs of heart failure after receiving anti-heart failure treatment during hospitalization, such as decreased exercise tolerance (dyspnea, fatigue), fluid retention, etc. Additionally, according to the 2024 Chinese guidelines for the diagnosis and treatment of heart failure consensus, patients eligible for this study will be classified based on ejection fraction into the following categories:
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Normal
There were no structural or functional abnormalities in the cardiac system, and no symptoms or signs of heart failure were observed.
Alternatively, the patient has developed organic heart disease without exhibiting any symptoms or signs of heart failure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cardiac Dysfunction
Time Frame: Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.
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The pathophysiology of heart failure encompasses a multifaceted clinical syndrome: 1)Cardiac structural and/or functional abnormalities resulting in impaired ventricular diastolic function and/or systolic ejection capacity;2)Corresponding clinical manifestations indicative of heart failure; 3)Typically accompanied by elevated levels of beneficial natriuretic peptide(BNP), as well as pulmonary or systemic congestion suggestive of cardiac origin on imaging studies, or objective evidence of increased ventricular filling pressure on hemodynamic assessments.4)According
to the classification of left ventricular ejection fraction (LVEF) based on cardiac ultrasound, heart failure can be categorized into four types: reduced ejection fraction heart failure (HFrEF), improving ejection fraction heart failure (HFimpEF), moderately reduced ejection fraction heart failure (HFmrEF), and retained ejection fraction heart failure (HFpEF).
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Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sixiang Jia, MD, The Fourth Hospital Affiliated to Zhejiang University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2024-108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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