Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06444425

Artificial Intelligence in Detecting Cardiac Function

The Korotkoff Sounds(KS), which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Given the increasing incidence of heart failure (HF), there is a pressing need for a rapid and convenient prehospital screening method. In this study, we propose employing deep learning (DL) techniques to explore the feasibility of utilizing KS methodology in predicting functional changes in cardiac ejection fraction (LVEF) as an indicator of cardiac dysfunction.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fourth Hospital Affiliated to Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cardiac Dysfunction

    Time frame: Evaluation LVEF:Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.

    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).

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Collaborators

  • Hong Kong Applied Science and Technology Research Institute
  • The People's Hospital of Quzhou
  • Zhejiang Quhua Hospital
  • Zhejiang Taizhou hospital

Registry information

Official study title

Korotkoff Sounds Dynamically Reflect Changes in Cardiac Function Based on Deep Learning Methods: A Prospective, Multicenter Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 5, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.