A Study to Evaluate Accuracy and Validity of the "Chang Gung" Ventricular Systolic Dysfunction Screening Software
Condition: Left Ventricular Systolic Dysfunction
MeSH terms: Ventricular Dysfunction, Left; Systolic Murmurs
Study type: Interventional

Summary: 
      The purpose of this research is to test a software tool called the "Chang Gung" Ventricular
      Systolic Dysfunction screening software, which uses a 12-lead electrocardiogram to determine
      if a patient has left ventricular systolic dysfunction. The goal is to determine if the
      software can accurately identify patients with this condition, which would help doctors
      diagnose and treat it more effectively.

      The trial will involve using the software on patients and comparing its results to those
      obtained through echocardiograms, which are currently the gold standard for diagnosing left
      ventricular systolic dysfunction. Only patients who meet specific eligibility criteria will
      be able to participate in the trial, and the software will be administered by trained
      healthcare professionals.

      The study will help determine if the software is a useful tool for diagnosing left
      ventricular systolic dysfunction, which could lead to earlier diagnosis and better outcomes
      for patients. The research team will collect and analyze data on the accuracy of the software
      and its usability in clinical practice.

      Overall, this study will provide important information for doctors and patients about a new
      tool for diagnosing left ventricular systolic dysfunction.
    

Detailed description: 
      This is a retrospective study conducted in Taiwan that aimed to test the performance of
      "Chang Gung" Ventricular Systolic Dysfunction screening software using electrocardiogram
      (ECG) and echocardiography data. The study data was obtained from a database that includes
      six hospitals of Chang Gung Memorial Hospital, between January 1, 2006, and December 31,
      2019.

      The software was developed using a training set of 133,225 data and validated using a set of
      57,134 data. For clinical validation, a total of 1,172 test data were randomly selected from
      the testing set, stratified by hospital classification, age group and gender. The hospital
      classification, age group and gender ratios were based on the proportion of the testing data.
      The test data were also stratified by the presence or absence of left ventricular systolic
      dysfunction(LVSD) for test group and control group, defined as a heart output rate of less
      than 40% within 14 days before and after the ECG recording.

      During the clinical trial, a cardiologist with 15 years of experience in treating
      cardiovascular disease examined the ECG data without any exclusion criteria. The cardiologist
      also confirmed the accuracy of the left ventricular ejection fraction (LVEF) measurement,
      which was defined as LVSD in the echocardiography reports. The LVEF was extracted from
      legally-binding echocardiography reports, not by the cardiologist during the clinical trial.
      The ECG data were screened and filtered for quality before being input into the software. The
      primary outcome was the sensitivity of the software, which was defined as not inferior to
      0.86. The study also analyzed secondary outcome measures, including the area under the
      receiver operating characteristic curve, accuracy, specificity, positive predictive value,
      negative predictive value, false-positive rate, and false-negative rate.
    

Intervention name(s): "Chang Gung" Ventricular Systolic Dysfunction Screening Software
Intervention type(s): Device
Intervention description(s): This software is suitable for 12-lead ECG signals of adults over 20 years old, and assists doctors in screening patients for left ventricular systolic dysfunction.
Intervention model: Single Group Assignment
Intervention model description: The investigators collected retrospective data and gave to the software to interpret. Echocardiography as the gold standard, and tested whether the software could correctly interpret left ventricular systolic dysfunction.
Masking: None (Open Label)
Primary purpose: Diagnostic