Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
Journal website https://cr.elmerpub.com

Original Article

Volume 16, Number 3, June 2025, pages 225-237

Validation of Decisions for Percutaneous Coronary Intervention Using Smartphone-Based Electrocardiogram Device Spandan: A Cross-Sectional Observational Study

Figures

Figure 1.
Figure 1. Spandan portable ECG developed by Sunfox Technologies Pvt. Ltd. A smartphone-based portable ECG device that is capable of taking 12-lead ECGs by using derived ECG methods to evaluate STEMI/NSTEMI. ECG: electrocardiogram; NSTEMI: non-ST-elevation myocardial infarction; STEMI: ST-elevation myocardial infarction.
Figure 2.
Figure 2. (a) A gold standard ECG test report. The patient’s report indicates ST-elevation, with the test performed on November 24, 2023 at 12:05 pm. (b) Spandan ECG test report. The patient’s report indicates ST-elevation, with the test performed on November 24, 2023 at 4:24 pm. ECG: electrocardiogram.
Figure 3.
Figure 3. Spandan ECG device algorithm for detecting STEMI. ECG: electrocardiogram.
Figure 4.
Figure 4. STORBE flow chart of the study. Flow diagram for the inclusion of patients in this study from May 16, 2023 to November 24, 2023 according to the Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) studies.
Figure 5.
Figure 5. A gold standard ECG test report. The patient’s report indicates anterolateral MI and the test was performed on November 20, 2023. ECG: electrocardiogram; MI: myocardial infarction.Spandan ECG test report. The patient’s report indicates anterolateral MI and the test was performed on November 20, 2023. ECG: electrocardiogram; MI: myocardial infarction.
Figure 6.
Figure 6. Spandan ECG test report. The patient’s report indicates anterolateral MI and the test was performed on November 20, 2023. ECG: electrocardiogram; MI: myocardial infarction.

Tables

Table 1. Baseline Characteristics of Patients
 
VariablesTotalPCI recommendedPCI not recommended
CAD: coronary artery disease; PCI: percutaneous coronary intervention.
Male1364591
Female481038
Diabetic33825
Smoking812853
CAD683236

 

Table 2. Classification of STEMI/NSTEMI Diagnosis in PCI Recommended Cases
 
ParametersTotal number of cases
NSTEMI: non-ST-elevation myocardial infarction; PCI: percutaneous coronary intervention; STEMI: ST-elevation myocardial infarction.
Anterior wall MI16
Anterolateral MI1
Anteroseptal MI33
Inferior wall MI7
Inferolateral MI6
Lateral wall MI1
Inferolateral ischemia6
Anteroseptal ischemia3
Anterior wall ischemia1
Inferior wall ischemia1
Lateral wall ischemia6
Ischemia4

 

Table 3. Standard Deviation of Difference in ST-Elevation of Spandan ECG and Gold Standard ECG
 
LeadsStandard deviation (mm)
ECG: electrocardiogram.
V10.5151378489
V20.6471798443
V30.8116491919
V40.8020386482
V50.4407447019
V60.3333333333
I0.161807967
AVL0.1518682754
II0.1336360201
III0.06741998625
AVF0.0944592977

 

Table 4. P-Value of All the Leads of the ST-Elevation Obtained From the Spandan ECG and Gold Standard ECG
 
LeadsP-value (two-tailed)
ECG: electrocardiogram.
V10.9909203153
V20.8285679301
V30.7806998477
V40.8611220978
V50.8769113181
V61
I0.7324147294
AVL0.8340370406
II0.7250799428
III0.9309606195
AVF0.8496250343

 

Table 5. Pearson Correlation of All Leads of the ST-Elevation Obtained From the Spandan ECG and Gold Standard ECG
 
LeadsCorrelation
ECG: electrocardiogram.
V10.8182728113
V20.864204206
V30.8493956246
V40.8833404998
V50.9443084849
V60.908508351
I1
AVL0.7825253865
II0.9830217466
III0.9929328666
AVF0.9839417391

 

Table 6. Comparative Diagnostic Performance of Spandan ECG and Gold Standard 12-Lead ECG for ST-Elevation Detection
 
MetricSpandan ECGGold standard ECG
ECG: electrocardiogram.
True positive4949
True negative00
False positive32
False negative34
Sensitivity94%92%
Positive predictive value94%96%

 

Table 7. Confounding Factor - Variability in Patient Demographics
 
Chest pain with STEMI patientsPCI recommendedPCI not recommended
PCI: percutaneous coronary intervention; STEMI: ST-elevation myocardial infarction.
Total patients55129
Patients with diabetes
  Total patients825
  Male517
  Female38
  Age group (more prevalent)41 - 6041 - 60
Patient with a history of smoking
  Total patients2853
  Male2748
  Female15
  Age group (more prevalent)41 - 6041 - 60