Design and technical validation to generate a synthetic 12-lead electrocardiogram dataset to promote artificial intelligence research.

Purpose: The purpose of this study is to construct a synthetic dataset of ECG signal that overcomes the sensitivity of personal information and the complexity of disclosure policies. Methods: The public dataset was constructed by generating synthetic data based on the deep learning model using a convolution neural network (CNN) and bi-directional long short-term memory (Bi-LSTM), and the effectiveness of the dataset was verified by developing classification models for ECG diagnoses. Results: The synthetic 12-lead ECG dataset generated consists of a total of 6000 ECGs, with normal and 5 abnormal groups. The synthetic ECG signal has a waveform pattern similar to the original ECG signal, the average RMSE between the two signals is 0.042 µV, and the average cosine similarity is 0.993. In addition, five classification models were developed to verify the effect of the synthetic dataset and showed performance similar to that of the model made with the actual dataset. In particular, even when the real dataset was applied as a test set to the classification model trained with the synthetic dataset, the classification performance of all models showed high accuracy (average accuracy 93.41%). Conclusion: The synthetic 12-lead ECG dataset was confirmed to perform similarly to the real-world 12-lead ECG in the classification model. This implies that a synthetic dataset can perform similarly to a real dataset in clinical research using AI. The synthetic dataset generation process in this study provides a way to overcome the medical data disclosure challenges constrained by privacy rights, a way to encourage open data policies, and contribute significantly to promoting cardiovascular disease research.