N/A
N=3,000
Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction
Myocardial Infarction · Acute Coronary Syndrome · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT04022668 ↗Enrolled (actual)
3,000
Serious AEs
3.7%
Results posted
Nov 2020
Primary outcome: Primary: The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. — 767; 282; 16 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Coronary angiogram (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yeditepe University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. |
767; 282; 16 | — |
| SECONDARY The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion. |
233; 0; 3 | — |
| SECONDARY The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion |
0; 41; 5 | — |
| SECONDARY The Specificity of ECG With STEMI Criteria |
233; 3; 70 | — |
| SECONDARY The Sensitivity of ECG With STEMI Criteria |
123; 3; 64 | — |
| SECONDARY The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) |
135; 60; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Admission to emergency department with a clinical picture suggestive of acute coronary syndrome
Exclusion Criteria
- Absence of documented ECG
- Age <18 years
Data sourced from ClinicalTrials.gov (NCT04022668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.