Trial Outcomes & Findings for Evaluation of Synthesized 18-Lead ECG in the Emergency Department (NCT NCT03426436)
NCT ID: NCT03426436
Last Updated: 2019-11-25
Results Overview
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
314 participants
Primary outcome timeframe
30 minutes
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
Test
Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
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|---|---|
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Overall Study
STARTED
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314
|
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Overall Study
COMPLETED
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295
|
|
Overall Study
NOT COMPLETED
|
19
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Reasons for withdrawal
| Measure |
Test
Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
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|---|---|
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Overall Study
Incorrect lead placement
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12
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Overall Study
Withdrawal by Subject
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2
|
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Overall Study
Consent issue
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1
|
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Overall Study
ECGs not saved
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test
n=295 Participants
Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
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|---|---|
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Age, Continuous
|
59 years
STANDARD_DEVIATION 15 • n=295 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=295 Participants
|
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Sex: Female, Male
Male
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145 Participants
n=295 Participants
|
|
Region of Enrollment
United States
|
295 participants
n=295 Participants
|
PRIMARY outcome
Timeframe: 30 minutesSensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.
Outcome measures
| Measure |
All Participants
n=295 Participants
Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
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|---|---|
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Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Elevation Sensitivity
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100 percentage of participants
Interval 100.0 to 100.0
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|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Elevation Specificity
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Elevation PPV
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Elevation NPV
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Depression Sensitivity
|
100 percentage of participants
Interval 100.0 to 100.0
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|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Depression Specificity
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Depression PPV
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Depression NPV
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
T Wave Inversion Sensitivity
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95 percentage of participants
Interval 92.0 to 97.0
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Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
T Wave Inversion Specificity
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80 percentage of participants
Interval 68.0 to 92.0
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Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
T Wave Inversion PPV
|
97 percentage of participants
Interval 95.0 to 99.0
|
|
Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
T Wave Inversion NPV
|
70 percentage of participants
Interval 56.0 to 83.0
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PRIMARY outcome
Timeframe: 30 minutesKappa value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.
Outcome measures
| Measure |
All Participants
n=295 Participants
Obtain two consecutive 15-lead ECGs; The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
Two consecutive 15-lead ECGs: The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
|
|---|---|
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Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Elevation
|
1.00 Kappa
Interval 1.0 to 1.0
|
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Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
ST Depression
|
1.00 Kappa
Interval 1.0 to 1.0
|
|
Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion
T Wave Inversion
|
0.70 Kappa
Interval 0.58 to 0.82
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Adverse Events
Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Research for Emergency Medicine
North Shore University Hospital
Phone: (516) 562-1513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60