Condition or disease | Intervention/treatment |
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Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease | Radiation: Coronary angiogram |
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to be highly correlated with ACO OR cardiac arrest in a clinical scenario compatible with ACO before blood could be withdrawn for troponin essay.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.
Study Type : | Observational |
Actual Enrollment : | 3000 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion |
Actual Study Start Date : | May 1, 2017 |
Actual Primary Completion Date : | May 1, 2020 |
Actual Study Completion Date : | May 1, 2020 |
Group/Cohort | Intervention/treatment |
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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.
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Radiation: Coronary angiogram
Routine coronary angiogram, if indicated
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NSTEMI
Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
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Radiation: Coronary angiogram
Routine coronary angiogram, if indicated
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Dr. Siyami Ersek Training and Research Hospital | |
Istanbul, Turkey, 34668 |
Tracking Information | |||||
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First Submitted Date | July 8, 2019 | ||||
First Posted Date | July 17, 2019 | ||||
Results First Submitted Date | August 17, 2020 | ||||
Results First Posted Date | November 10, 2020 | ||||
Last Update Posted Date | November 10, 2020 | ||||
Actual Study Start Date | May 1, 2017 | ||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. [ Time Frame: 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.
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Original Primary Outcome Measures |
The sensitivity and specificity of ECG [ Time Frame: Up to 48 hours ] Determine the sensitivity and specificity of different ECG findings for acute coronary occlusion
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction | ||||
Official Title | Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Acute coronary syndrome | ||||
Condition |
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Intervention | Radiation: Coronary angiogram
Routine coronary angiogram, if indicated
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Study Groups/Cohorts |
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Publications * | Aslanger EK, Yıldırımtürk Ö, Şimşek B, Bozbeyoğlu E, Şimşek MA, Yücel Karabay C, Smith SW, Değertekin M. DIagnostic accuracy oF electrocardiogram for acute coronary OCClUsion resuLTing in myocardial infarction (DIFOCCULT Study). Int J Cardiol Heart Vasc. 2020 Jul 30;30:100603. doi: 10.1016/j.ijcha.2020.100603. eCollection 2020 Oct. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
3000 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | May 1, 2020 | ||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04022668 | ||||
Other Study ID Numbers | YeditepeU001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Yeditepe University | ||||
Study Sponsor | Yeditepe University | ||||
Collaborators | Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital | ||||
Investigators | Not Provided | ||||
PRS Account | Yeditepe University | ||||
Verification Date | October 2020 |