An observational study in Left Ventricular Systolic Dysfunction, sponsored by Seoul National University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by Seoul National University Hospital · Observational
The purpose of the current study is to verify the effectiveness of the artificial intelligence algorithm applied to the electrocardiogram as a potential screening tool for left ventricular systolic dysfunction.
The current investigators have developed an artificial intelligence (AI) algorithm based on 12-lead electrocardiogram (ECG) detecting left ventricular systolic dysfunction, through 364,845 ECGs from 148,547 patients. Then, when the model was tested retrospectively on 59,805 ECGs of 24,376 patients, the model performance expressed as an area under the receiver operating characteristic curve was 0.889 (95% CI 0.887-0.891).
The investigators are planning to prospectively validate the model's effectiveness as a potential screening tool for left ventricular systolic dysfunction.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 1,530 is above the median of 198 across 103 observational studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing 12-lead ECG and transthoracic echocardiography in routine clinical practice
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12-lead ECG is performed for each patient. For 12-lead ECG, AITIALVSD (AI algorithm) analysis will be performed through a separate server.
Area under the receiver operating characteristic curve (AUROC)
AI model performance detecting LVSD, expressed as an AUROC. As a diagnostic assistance for LVSD, an ROC curve expressed as sensitivity to (1-specificity) will be presented, and the accuracy of prediction will be confirmed by calculating the AUROC, which is the area below.
Time frame: Through study completion, an average of 1 year
Sensitivity
AI model sensitivity detecting LVSD
Time frame: Through study completion, an average of 1 year
Specificity
AI model sensitivity detecting patients with normal left ventricular systolic function
Time frame: Through study completion, an average of 1 year
Positive predictive value
Positive predictive value in the recruited patient population
Time frame: Through study completion, an average of 1 year
Negative predictive value
Negative predictive value in the recruited patient population
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Ventricular Dysfunction, Left →
Seoul National University Hospital →