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

NCT04022668 | Completed Results

• 1 other identifier: YeditepeU001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion.

  Up to 48 hours

• The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion

  Up to 48 hours

• The Specificity of ECG With STEMI Criteria

  Up to 48 hours

• The Sensitivity of ECG With STEMI Criteria

  Up to 48 hours

• The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)

  Up to one year

Study Arms (3)

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

NSTEMI

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

Radiation: Coronary angiogram

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

Interventions

Coronary angiogram RADIATION

Routine coronary angiogram, if indicated

NSTEMI; STEMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute coronary syndrome

You may qualify if:

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

You may not qualify if:

• Absence of documented ECG
• Age \<18 years

Sponsors & Collaborators

• Yeditepe University: lead
• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: collaborator

Study Sites (1)

Dr. Siyami Ersek Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32775606 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Coronary Occlusion; Coronary Thrombosis; Myocardial Ischemia; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Thrombosis; Embolism and Thrombosis

Results Point of Contact

• Title: Emre Aslanger
• Organization: Yeditepe University

mr_aslanger@hotmail.com

0216578000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 17, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 10, 2020
• Results First Posted: November 10, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)