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出境医 / 临床实验 / Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction (DIFOCCULT)

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

Study Description
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.

Condition or disease Intervention/treatment
Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease 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 Design
Layout table for study information
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
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion. [ Time Frame: Up to 48 hours ]
    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.

  2. The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion [ Time Frame: Up to 48 hours ]
    Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria. Only type 1b ECGs will be included in this group.

  3. The Specificity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false positive STEMI criteria. Only type 1c and 1d ECGs will be included in this group.

  4. The Sensitivity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false negative STEMI criteria. The occurrence of type 1c ECGs in subgroups will be compared.

  5. The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) [ Time Frame: Up to one year ]
    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.


Eligibility Criteria
Layout table for eligibility information
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
Study Population
Acute coronary syndrome
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
Contacts and Locations

Locations
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Turkey
Dr. Siyami Ersek Training and Research Hospital
Istanbul, Turkey, 34668
Sponsors and Collaborators
Yeditepe University
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Tracking Information
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
 (submitted: October 22, 2020)
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.
Original Primary Outcome Measures
 (submitted: July 16, 2019)
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
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2020)
  • The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion. [ Time Frame: Up to 48 hours ]
    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.
  • The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion [ Time Frame: Up to 48 hours ]
    Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria. Only type 1b ECGs will be included in this group.
  • The Specificity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false positive STEMI criteria. Only type 1c and 1d ECGs will be included in this group.
  • The Sensitivity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false negative STEMI criteria. The occurrence of type 1c ECGs in subgroups will be compared.
  • The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups) [ Time Frame: Up to one year ]
    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.
Original Secondary Outcome Measures
 (submitted: July 16, 2019)
  • The sensitivity and specificity of current criteria [ Time Frame: Up to 48 hours ]
    Determine the accuracy of current ECG criteria in diagnosing acute coronary occlusion
  • The sensitivity and specificity of ECG without ST-segment elevation [ Time Frame: Up to 48 hours ]
    Determine the accuracy of ECG interpretation of acute coronary occlusion without STEMI criteria
  • The Specificity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false positive STEMI criteria
  • The Sensitivity of ECG With STEMI Criteria [ Time Frame: Up to 48 hours ]
    Explore the rationale for correct ECG interpretation of false negative STEMI criteria
  • The outcome according to ECG subclassifications [ Time Frame: Up to one year ]
    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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Acute coronary syndrome
Condition
  • Myocardial Infarction
  • Acute Coronary Syndrome
  • Coronary Artery Disease
Intervention Radiation: Coronary angiogram
Routine coronary angiogram, if indicated
Study Groups/Cohorts
  • 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.
    Intervention: Radiation: Coronary angiogram
  • NSTEMI
    Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria.
    Intervention: 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
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2019)
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:

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

Exclusion Criteria:

  • Absence of documented ECG
  • Age <18 years
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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