Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
Acute Coronary Occlusion, Occlusive Myocardial Infarction, Non-occlusive Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Occlusion, Coronary Thrombosis, Myocardial Ischemia, Coronary Disease
Brief summary
The decision of emergency reperfusion of a suspected acute coronary artery occlusion by means of percutaneous coronary intervention or intravenous thrombolytics depends on the presence of a certain amount of ST-segment elevation in the electrocardiogram (ECG) as recommended by international guidelines. However, recommended ST-segment elevation cut-off values for acute coronary occlusion diagnosis are highly insensitive, and their evidence base is weak. The objective of this study is to test the accuracy of various electrocardiographic patterns (including, but not limited to, ST-segment elevation) for the diagnosis of acute coronary occlusion. This information can serve to offer an accuracy profile for various ECG findings and enable clinicians to define the ECG probability of an acute coronary occlusion according to these ECG findings and clinical picture, which in turn would provide a significant improvement in the care for patients who present to the hospital with possible coronary occlusion. The primary analysis will be designed as a single-center, retrospective case-control study.
Detailed description
In this retrospective, single-center, case-control study the investigators will seek to compare the diagnostic accuracy of various ECG criteria to identify acute coronary occlusion (ACO). The investigators will scan the charts of the patients presenting to emergency department with a clinical picture suggestive of acute coronary syndrome in the specified time period. Patients without any admission ECG will be excluded. Patients who had a final diagnosis of myocardial infarction (MI) with or without subsequent coronary intervention will be enrolled. These patients will be classified as ST-segment elevation (STEMI) group or non-ST-segment elevation (NSTEMI) group according to their final diagnosis. Patient who had been excluded for acute coronary syndrome with serial unchanging ECGs AND negative serial troponins will constitute a third group. Allocation to each group will be continued until the patient number in each group reaches up to 1000 patients. The dead or alive status of all included patients will be checked from the electronic national database. All ECGs will be reviewed by two cardiologists blinded to the angiographic and clinical outcomes. The presence of predefined ECG findings of ACO (including, but not limited to, current established STEMI criteria) will be recorded. The coronary angiograms of the first two groups will be reviewed for ACO by independent investigators who are blinded to ECG parameters. The diagnosis of acute coronary occlusion will be dependent upon angiographic occlusion and rising cardiac biomarker levels. Because in some cases of ACO, the artery may spontaneously open by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit lesion OR acute occlusion on the angiogram AND a sufficiently elevated peak troponin, i.e., peak troponin I \> 1.0 ng/mL with a 20% change within first 24 hours OR peak troponin T \> 5.0 ng/mL, which have been shown to be highly correlated with ACO OR cardiac arrest in a clinical scenario compatible with ACO before blood could be withdrawn for troponin essay. The sensitivity, specificity and diagnostic accuracy of all these predefined ECG criteria will be sought. Also, sensitivity, specificity and diagnostic accuracy of current established STEMI criteria will be defined. Both short- and long-term mortality of the patients with a diagnosis of STEMI with ACO, STEMI without ACO, NSTEMI with ACO, NSTEMI without ACO and chest pain without acute coronary syndrome will be compared.
Interventions
Routine coronary angiogram, if indicated
Sponsors
Study design
Eligibility
Inclusion criteria
* Admission to emergency department with a clinical picture suggestive of acute coronary syndrome
Exclusion criteria
* Absence of documented ECG * Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. | Up to 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion. | Up to 48 hours | 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. |
| The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion | Up to 48 hours | Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria. Only type 1b ECGs will be included in this group. |
| The Specificity of ECG With STEMI Criteria | Up to 48 hours | Explore the rationale for correct ECG interpretation of false positive STEMI criteria. Only type 1c and 1d ECGs will be included in this group. |
| The Sensitivity of ECG With STEMI Criteria | Up to 48 hours | Explore the rationale for correct ECG interpretation of false negative STEMI criteria. The occurrence of type 1c ECGs in subgroups will be compared. |
| The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) | Up to one year | Compare the outcomes of the patients who are labeled as STEMI and the patients who are labeled as having NSTEMI but have acute coronary occlusion. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,000 |
| NSTEMI Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
Coronary angiogram: Routine coronary angiogram, if indicated | 1,000 |
| 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 | 1,000 |
| Total | 3,000 |
Baseline characteristics
| Characteristic | STEMI | Total | Normal | NSTEMI |
|---|---|---|---|---|
| Admission troponin | 3.462 ng/ml | 0.155 ng/ml | 0.002 ng/ml | 0.403 ng/ml |
| Age, Continuous | 61 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 15 | 48 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 13 |
| Creatinine | 0.8 mg/dL | 0.8 mg/dL | 0.8 mg/dL | 0.9 mg/dL |
| Diabetes | 292 Participants | 746 Participants | 83 Participants | 371 Participants |
| Dyslipidemia | 276 Participants | 850 Participants | 207 Participants | 367 Participants |
| Electrocardiogram to percutaneous coronary intervention time | 40 minutes | 90 minutes | NA minutes | 2160 minutes |
| Grace risk score | 147 units on a scale | 143 units on a scale | 129 units on a scale | 142 units on a scale |
| Heart rate | 80 bpm | 79 bpm | 77 bpm | 81 bpm |
| Hemoglobin | 13.7 g/dL | 13.6 g/dL | 13.9 g/dL | 13.3 g/dL |
| Hypertension | 481 Participants | 1250 Participants | 195 Participants | 574 Participants |
| Prior coronary artery by-pass operation | 55 Participants | 214 Participants | 63 Participants | 96 Participants |
| Prior myocardial infarction | 185 Participants | 548 Participants | 89 Participants | 274 Participants |
| Prior percutaneous coronary intervention (PCI) | 150 Participants | 474 Participants | 111 Participants | 213 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1000 Participants | 3000 Participants | 1000 Participants | 1000 Participants |
| Region of Enrollment Turkey | 1000 participants | 3000 participants | 1000 participants | 1000 participants |
| Sex: Female, Male Female | 243 Participants | 931 Participants | 354 Participants | 334 Participants |
| Sex: Female, Male Male | 757 Participants | 2069 Participants | 646 Participants | 666 Participants |
| Smoking | 514 Participants | 1412 Participants | 483 Participants | 415 Participants |
| Systolic blood pressure | 136 mmHg STANDARD_DEVIATION 33 | 140 mmHg STANDARD_DEVIATION 30 | 139 mmHg STANDARD_DEVIATION 24 | 146 mmHg STANDARD_DEVIATION 28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 135 / 1,000 | 60 / 1,000 | 1 / 1,000 |
| other Total, other adverse events | 0 / 1,000 | 0 / 1,000 | 0 / 1,000 |
| serious Total, serious adverse events | 83 / 1,000 | 27 / 1,000 | 0 / 1,000 |
Outcome results
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion.
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.
Time frame: Up to 48 hours
Population: The occurrence of type 1a and 1b ECGs in subgroups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. | 767 Participants |
| NSTEMI | The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. | 282 Participants |
| Normal | The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. | 16 Participants |
The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)
Compare the outcomes of the patients who are labeled as STEMI and the patients who are labeled as having NSTEMI but have acute coronary occlusion.
Time frame: Up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) | 135 Participants |
| NSTEMI | The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) | 60 Participants |
| Normal | The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) | 1 Participants |
The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion.
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.
Time frame: Up to 48 hours
Population: THe occurrence of type 1c and 1d ECGs in subgroups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion. | 233 Participants |
| NSTEMI | The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion. | 0 Participants |
| Normal | The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion. | 3 Participants |
The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion
Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria. Only type 1b ECGs will be included in this group.
Time frame: Up to 48 hours
Population: The occurrence of type 1b ECGs in subgroups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion | 0 Participants |
| NSTEMI | The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion | 41 Participants |
| Normal | The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion | 5 Participants |
The Sensitivity of ECG With STEMI Criteria
Explore the rationale for correct ECG interpretation of false negative STEMI criteria. The occurrence of type 1c ECGs in subgroups will be compared.
Time frame: Up to 48 hours
Population: The occurrence of type 1c ECGs in subgroups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Sensitivity of ECG With STEMI Criteria | 123 Participants |
| NSTEMI | The Sensitivity of ECG With STEMI Criteria | 3 Participants |
| Normal | The Sensitivity of ECG With STEMI Criteria | 64 Participants |
The Specificity of ECG With STEMI Criteria
Explore the rationale for correct ECG interpretation of false positive STEMI criteria. Only type 1c and 1d ECGs will be included in this group.
Time frame: Up to 48 hours
Population: The sum of type 1c and 1d ECGs in subgroups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STEMI | The Specificity of ECG With STEMI Criteria | 233 Participants |
| NSTEMI | The Specificity of ECG With STEMI Criteria | 3 Participants |
| Normal | The Specificity of ECG With STEMI Criteria | 70 Participants |