Myocardial InfarctionDIFOCCULTNCT04022668
Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Coronary angiogram
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 1 May 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute coronary syndrome
Who may be able to join
- Admission to emergency department with a clinical picture suggestive of acute coronary syndrome
Who cannot join
- Absence of documented ECG
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Siyami Ersek Training and Research Hospital
Istanbul, 34668
About this study
Official title: 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.
Read the 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.
- Being tested
- Coronary angiogram
- 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
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Coronary Occlusion, Coronary Thrombosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiogramRadiation
Routine coronary angiogram, if indicated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Coronary angiogram | |
| NSTEMI | Troponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 May 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022668
- Sponsor's protocol ID
- YeditepeU001
- Acronym
- DIFOCCULT
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2019
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32775606
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion
- ClinicalTrials.gov ID
- NCT04022668
- Acronym / sponsor ID
- DIFOCCULT / YeditepeU001
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 10 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Radiation: Coronary angiogramCurrent 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. |
| NSTEMI | – | Radiation: Coronary angiogramTroponin rise above 99th percentile in a clinical situation suggestive of myocardial ischemia without abovementioned criteria. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome
Key inclusion criteria (1 listed)
- Admission to emergency department with a clinical picture suggestive of acute coronary syndrome
Key exclusion criteria (2 listed)
- Absence of documented ECG
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiogramRoutine coronary angiogram, if indicated | Radiation | NSTEMI, STEMI |
Primary outcome
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.
5 secondary outcomes
The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion.
Time frame: Up to 48 hours
The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion
Time frame: Up to 48 hours
The Specificity of ECG With STEMI Criteria
Time frame: Up to 48 hours
The Sensitivity of ECG With STEMI Criteria
Time frame: Up to 48 hours
The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)
Time frame: Up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32775606Aslanger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.