Trial Outcomes & Findings for Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction (NCT NCT04022668)
NCT ID: NCT04022668
Last Updated: 2020-11-10
Results Overview
Determine the sensitivity and specificity of different ECG findings for acute coronary occlusion. The Number of Participants with Type 1a and 1b ECGs, as defined in the study protocol.
Recruitment status
COMPLETED
Target enrollment
3000 participants
Primary outcome timeframe
Up to 48 hours
Results posted on
2020-11-10
Participant Flow
Participant milestones
| Measure |
STEMI
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
Overall Study
STARTED
|
1000
|
1000
|
1000
|
|
Overall Study
COMPLETED
|
986
|
973
|
1000
|
|
Overall Study
NOT COMPLETED
|
14
|
27
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction
Baseline characteristics by cohort
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
Total
n=3000 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=5 Participants
|
61 years
STANDARD_DEVIATION 13 • n=7 Participants
|
48 years
STANDARD_DEVIATION 16 • n=5 Participants
|
56 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
931 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
757 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
646 Participants
n=5 Participants
|
2069 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1000 Participants
n=5 Participants
|
1000 Participants
n=7 Participants
|
1000 Participants
n=5 Participants
|
3000 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
1000 participants
n=5 Participants
|
1000 participants
n=7 Participants
|
1000 participants
n=5 Participants
|
3000 participants
n=4 Participants
|
|
Hypertension
|
481 Participants
n=5 Participants
|
574 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
1250 Participants
n=4 Participants
|
|
Dyslipidemia
|
276 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
850 Participants
n=4 Participants
|
|
Diabetes
|
292 Participants
n=5 Participants
|
371 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
746 Participants
n=4 Participants
|
|
Smoking
|
514 Participants
n=5 Participants
|
415 Participants
n=7 Participants
|
483 Participants
n=5 Participants
|
1412 Participants
n=4 Participants
|
|
Prior myocardial infarction
|
185 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
548 Participants
n=4 Participants
|
|
Prior percutaneous coronary intervention (PCI)
|
150 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
474 Participants
n=4 Participants
|
|
Prior coronary artery by-pass operation
|
55 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Systolic blood pressure
|
136 mmHg
STANDARD_DEVIATION 33 • n=5 Participants
|
146 mmHg
STANDARD_DEVIATION 28 • n=7 Participants
|
139 mmHg
STANDARD_DEVIATION 24 • n=5 Participants
|
140 mmHg
STANDARD_DEVIATION 30 • n=4 Participants
|
|
Heart rate
|
80 bpm
n=5 Participants
|
81 bpm
n=7 Participants
|
77 bpm
n=5 Participants
|
79 bpm
n=4 Participants
|
|
Electrocardiogram to percutaneous coronary intervention time
|
40 minutes
n=5 Participants
|
2160 minutes
n=7 Participants
|
NA minutes
n=5 Participants
|
90 minutes
n=4 Participants
|
|
Grace risk score
|
147 units on a scale
n=5 Participants
|
142 units on a scale
n=7 Participants
|
129 units on a scale
n=5 Participants
|
143 units on a scale
n=4 Participants
|
|
Creatinine
|
0.8 mg/dL
n=5 Participants
|
0.9 mg/dL
n=7 Participants
|
0.8 mg/dL
n=5 Participants
|
0.8 mg/dL
n=4 Participants
|
|
Hemoglobin
|
13.7 g/dL
n=5 Participants
|
13.3 g/dL
n=7 Participants
|
13.9 g/dL
n=5 Participants
|
13.6 g/dL
n=4 Participants
|
|
Admission troponin
|
3.462 ng/ml
n=5 Participants
|
0.403 ng/ml
n=7 Participants
|
0.002 ng/ml
n=5 Participants
|
0.155 ng/ml
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hoursPopulation: The occurrence of type 1a and 1b ECGs in subgroups
Determine the sensitivity and specificity of different ECG findings for acute coronary occlusion. The Number of Participants with Type 1a and 1b ECGs, as defined in the study protocol.
Outcome measures
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion.
|
767 Participants
|
282 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: THe occurrence of type 1c and 1d ECGs in subgroups
Determine the accuracy of current "STEMI" ECG criteria (as reported in the 4th universal definition of MI) in diagnosing acute coronary occlusion. Type 1a, 1c and 1d ECGs will be included in this group.
Outcome measures
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion.
|
233 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The occurrence of type 1b ECGs in subgroups
Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria. Only type 1b ECGs will be included in this group.
Outcome measures
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion
|
0 Participants
|
41 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The sum of type 1c and 1d ECGs in subgroups
Explore the rationale for correct ECG interpretation of false positive STEMI criteria. Only type 1c and 1d ECGs will be included in this group.
Outcome measures
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Specificity of ECG With STEMI Criteria
|
233 Participants
|
3 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The occurrence of type 1c ECGs in subgroups
Explore the rationale for correct ECG interpretation of false negative STEMI criteria. The occurrence of type 1c ECGs in subgroups will be compared.
Outcome measures
| Measure |
STEMI
n=1000 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Sensitivity of ECG With STEMI Criteria
|
123 Participants
|
3 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Up to one yearCompare the outcomes of the patients who are labeled as STEMI and the patients who are labeled as having NSTEMI but have acute coronary occlusion.
Outcome measures
| Measure |
STEMI
n=986 Participants
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=973 Participants
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 Participants
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)
|
135 Participants
|
60 Participants
|
1 Participants
|
Adverse Events
STEMI
Serious events: 83 serious events
Other events: 0 other events
Deaths: 135 deaths
NSTEMI
Serious events: 27 serious events
Other events: 0 other events
Deaths: 60 deaths
Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
STEMI
n=1000 participants at risk
Current international ECG criteria (New ST-segment elevation at the J-point in two contiguous leads with the cut-points: ≥0.1 mV millivolts (mV) in all leads other than leads V2-V3; for leads V2-V3: ≥2 mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age) with troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia.
Coronary angiogram: Routine coronary angiogram, if indicated
|
NSTEMI
n=1000 participants at risk
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated
|
Normal
n=1000 participants at risk
Emergency department admission with a clinical picture compatible with acute coronary syndrome, but no change in serial ECGs and no rise in cardiac biomarkers
|
|---|---|---|---|
|
Cardiac disorders
In hospital mortality
|
8.3%
83/1000 • Number of events 83 • 1.5 years
Survival/mortality
|
2.7%
27/1000 • Number of events 27 • 1.5 years
Survival/mortality
|
0.00%
0/1000 • 1.5 years
Survival/mortality
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place