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Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction

Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04022668
Acronym
DIFOCCULT
Enrollment
3000
Registered
2019-07-17
Start date
2017-05-01
Completion date
2020-05-01
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease

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

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
CollaboratorOTHER
Yeditepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion.Up to 48 hoursDetermine 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

MeasureTime frameDescription
The Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion.Up to 48 hoursDetermine 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 OcclusionUp to 48 hoursDetermine 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 CriteriaUp to 48 hoursExplore 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 CriteriaUp to 48 hoursExplore 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 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.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
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
Total3,000

Baseline characteristics

CharacteristicSTEMITotalNormalNSTEMI
Admission troponin3.462 ng/ml0.155 ng/ml0.002 ng/ml0.403 ng/ml
Age, Continuous61 years
STANDARD_DEVIATION 13
56 years
STANDARD_DEVIATION 15
48 years
STANDARD_DEVIATION 16
61 years
STANDARD_DEVIATION 13
Creatinine0.8 mg/dL0.8 mg/dL0.8 mg/dL0.9 mg/dL
Diabetes292 Participants746 Participants83 Participants371 Participants
Dyslipidemia276 Participants850 Participants207 Participants367 Participants
Electrocardiogram to percutaneous coronary intervention time40 minutes90 minutesNA minutes2160 minutes
Grace risk score147 units on a scale143 units on a scale129 units on a scale142 units on a scale
Heart rate80 bpm79 bpm77 bpm81 bpm
Hemoglobin13.7 g/dL13.6 g/dL13.9 g/dL13.3 g/dL
Hypertension481 Participants1250 Participants195 Participants574 Participants
Prior coronary artery by-pass operation55 Participants214 Participants63 Participants96 Participants
Prior myocardial infarction185 Participants548 Participants89 Participants274 Participants
Prior percutaneous coronary intervention (PCI)150 Participants474 Participants111 Participants213 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1000 Participants3000 Participants1000 Participants1000 Participants
Region of Enrollment
Turkey
1000 participants3000 participants1000 participants1000 participants
Sex: Female, Male
Female
243 Participants931 Participants354 Participants334 Participants
Sex: Female, Male
Male
757 Participants2069 Participants646 Participants666 Participants
Smoking514 Participants1412 Participants483 Participants415 Participants
Systolic blood pressure136 mmHg
STANDARD_DEVIATION 33
140 mmHg
STANDARD_DEVIATION 30
139 mmHg
STANDARD_DEVIATION 24
146 mmHg
STANDARD_DEVIATION 28

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
135 / 1,00060 / 1,0001 / 1,000
other
Total, other adverse events
0 / 1,0000 / 1,0000 / 1,000
serious
Total, serious adverse events
83 / 1,00027 / 1,0000 / 1,000

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Sensitivity and Specificity of ECG for Acute Coronary Occlusion.767 Participants
NSTEMIThe Sensitivity and Specificity of ECG for Acute Coronary Occlusion.282 Participants
NormalThe Sensitivity and Specificity of ECG for Acute Coronary Occlusion.16 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)135 Participants
NSTEMIThe Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)60 Participants
NormalThe Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)1 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion.233 Participants
NSTEMIThe Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion.0 Participants
NormalThe Sensitivity and Specificity of Current STEMI Criteria for Acute Coronary Occlusion.3 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion0 Participants
NSTEMIThe Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion41 Participants
NormalThe Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion5 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Sensitivity of ECG With STEMI Criteria123 Participants
NSTEMIThe Sensitivity of ECG With STEMI Criteria3 Participants
NormalThe Sensitivity of ECG With STEMI Criteria64 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
STEMIThe Specificity of ECG With STEMI Criteria233 Participants
NSTEMIThe Specificity of ECG With STEMI Criteria3 Participants
NormalThe Specificity of ECG With STEMI Criteria70 Participants

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026