None listed
Conditions
Interventions
None listed
Sponsors
DeepCardio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who voluntarily agreed in writing to participate in this clinical study 2) adults over 19 years of age 3) Patients subjected to standard 12-lead ECG measurements during the study period 4) Those whose ECG at the time of inspection is sinus rhythm 5) Those who can measure 1-lead ECG additionally during the same visit
Exclusion criteria
Exclusion criteria: 1) A person who is difficult or inappropriate to conduct research as judged by the research manager 2) Patients with an atrial fibrillation or atrial flutter at the time of examination 3) Pacemaker-induced pacing rhythm patient 4) Those who have difficulty measuring 1-lead ECG due to severe Tremor, inability to cooperate, and skin conditions 5) A person who is likely to delay standard medical treatment due to a serious medical situation 6) A person who wishes to withdraw his/her consent or who does not consent to the use of personal information 7) ECG below quality standards (non-analytic level noise, lead disconnection, etc.) - However, the analysis impossibility evaluation can be recorded separately
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation coefficients (using Pearson or Spearman methods) to evaluate the correlation between 12-lead-based and 1-lead-based AI scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Performing ICC to evaluate the consistency between 12-lead AI score and 1-lead AI score (absolute agreement, two-way random model);Bland-Altman Analysis to Evaluate Consistency between 12-lead AI Score and 1-lead AI Score (Mean Difference and 95% Limits of Agreement);AUC (ROC), sensitivity, specificity, PPV, NPV of 12-lead and 1-lead based AI results compared to disease-specific reference standards;12 Lead vs. 1 Lead AUC Difference (DeLong Test If Required);Analyzability (non-analyzability), performance by signal quality rating;Exploratory Performance Comparison by Disease/Subgroup | — |
Countries
Korea, Republic of
Contacts
Public Contacthyerim park
Inha University Hospital
Outcome results
None listed