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

NCT ID: NCT04022668

Last Updated: 2020-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease

Keywords

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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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Coronary angiogram

Intervention Type RADIATION

Routine coronary angiogram, if indicated

NSTEMI

Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.

Coronary angiogram

Intervention Type RADIATION

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

No interventions assigned to this group

Interventions

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Coronary angiogram

Routine coronary angiogram, if indicated

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Admission to emergency department with a clinical picture suggestive of acute coronary syndrome

Exclusion Criteria

* Absence of documented ECG
* Age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Siyami Ersek Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Aslanger EK, Yildirimturk O, Simsek B, Bozbeyoglu E, Simsek MA, Yucel Karabay C, Smith SW, Degertekin 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.

Reference Type DERIVED
PMID: 32775606 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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YeditepeU001

Identifier Type: -

Identifier Source: org_study_id