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

Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Radiation: Coronary angiogram

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.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Dr. Siyami Ersek Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute coronary syndrome

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of documented ECG
• Age <18 years

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: Coronary angiogram; Routine coronary angiogram, if indicated
NSTEMI; Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.	Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 hours
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.	Up to 48 hours
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.	Up to 48 hours
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.	Up to 48 hours
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.	Up to one year

Collaborators and Investigators

• Sponsor: Yeditepe University
• Collaborators: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Myocardial Ischemia; Coronary Disease; Coronary Occlusion; Non-ST Elevated Myocardial Infarction; Acute Coronary Occlusion; Occlusive Myocardial Infarction; Non-occlusive Myocardial Infarction; ST Elevation Myocardial Infarction; Coronary Thrombosis
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Acute Coronary Syndrome; Coronary Occlusion
• Other Study ID Numbers: YeditepeU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No