Acute Coronary SyndromeNCT03863327
EKG Criteria and Identification of Acute Coronary Occlusion
An observational study of Acute Coronary Syndrome and STEMI, run by Stony Brook University at 2 sites in United States.
Trial summary
The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, STEMI, STEMI - ST Elevation Myocardial Infarction
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2018to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators plan to review and include all individuals that underwent urgent or emergent cardiac catheterization over the course of one year (January 1, 2017 - December 31, 2017).
Who may be able to join
- Recorded EKG prior to cardiac catheterization
Who cannot join
- Absence of documented EKG prior to cardiac catheterization
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Daniel Lee, MD
Daniel Lee, MD
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Harvey P Meyers, MD, 631-793-2148, harvey.meyers@stonybrookmedicine.edu
Alexander Bracey, MD, 631-358-6225, alexander.bracey@stonybrookmedicine.edu
About this study
The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart).
The primary analysis will be designed as a multi-center, retrospective case-control study.
Read the detailed description
In this retrospective, 2-center, case-control study the investigators will investigate and compare the accuracy of various ECG criteria and expert interpretation to diagnose Acute Coronary Occlusion (ACO), with an emphasis on the diagnosis of patients with ACO but without obvious ST segment Elevation Myocardial Infarction (STEMI) criteria. The investigators will use two cohorts of patients who present with symptoms consistent with acute MI, one subsequently proven to have ACO and one proven to not have ACO.
The groups will be identified by chart reviewers who will use all clinical data except the ECGs to determine, in retrospect, and using strict criteria, if the patient had ACO at the time of the ECGs to be evaluated, or not. These reviewers will be blinded to all ECGs. The diagnosis of ACO will be dependent upon angiographic occlusion. Because in many cases of ACO, the artery spontaneously opens by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit on the angiogram PLUS a very elevated peak troponin, as peak troponin I > 10.0 ng/mL and peak troponin T > 1.0 ng/mL are highly correlated with ACO.
The investigators will find cases of subtle STEMI (ACO without STEMI criteria) by searching for all myocardial infarction cases that underwent angiography and percutaneous coronary intervention (PCI). The investigators will attempt by various criteria to determine from all available sources other than the ECG (angiography, echo, troponins) whether the involved artery was occluded at the time of the most diagnostic ECG that was recorded while the patient had symptoms and before the angiogram. Reviewers determining ACO or not ACO will be blinded to the ECGs. The investigators will use each pre-angiogram ECG, in sequence, for analysis, to determine if expert interpretation can not only identify occlusion that is not identified by STEMI criteria, but also to find if expert interpretation can identify occlusion on an earlier ECG. Expert ECG interpreters will interpret the ECG for evidence of ACO. Their accuracy will be compared to traditional STEMI criteria and other methods of interpretation if available.
The investigators will use as controls patients with any ST elevation, or ST depression, of any etiology that are proven to NOT have occlusion. The investigators will establish absence of occlusion by a combination of objective data points including angiogram (if performed), troponins, echocardiograms, clinical course, etc. Details of the methods are below, including specific outcome definitions used to claim the presence or absence of ACO.
- Conditions
- Acute Coronary Syndrome, STEMI, STEMI - ST Elevation Myocardial Infarction, Acute Coronary Artery Thrombosis (Diagnosis), NSTEMI - Non-ST Segment Elevation MI, Non-ST Elevation Myocardial Infarction
- Being tested
- No intervention
- Keywords
- Acute Coronary Occlusion, ACO, Occlusive Myocardial Infarction, OMI, Non-occlusive Myocardial Infarction, NOMI
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Disease, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no intervention as a part of this protocol.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Occlusion or near-occlusion (TIMI 0-1) | a. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-1 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI > 10 ng/mL or cTnT > 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis. Receives: Other: No intervention | |
| Acute Coronary Occlusion or near-occlusion (TIMI 0-2) | a. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-2 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI > 10 ng/mL or cTnT > 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis. Receives: Other: No intervention | |
| Acute severe 3-vessel disease or critical left main stenosis | 1. Severe 3-vessel disease: >/=75% stenosis in all three major coronary vessels (or equivalents in the case of anatomic variants or preexisting bypass) with an acute culprit lesion (TIMI<3) or
2. Left main stenosis > 50% (see Smith review paper for reference): acute left main culprit of any TIMI score, or any lesion of the left main with TIMI<3 or
3. Any other cardiac catheterization findings prompting initiation of emergent coronary artery bypass grafting within the next 120 hours Receives: Other: No intervention | |
| No evidence of acute coronary occlusion | 1. At least three sequential negative cardiac biomarkers within 24 hours of presentation
2. cardiac catheterization showing no culprit lesion.
3. Angiogram showing an acute culprit lesion but both no occlusion (TIMI 2 or greater) and troponins not exceeding the cutoff above
4. If positive troponin values present but no angiography, then the patient must have echocardiography showing no wall motion abnormality and troponin values less than the above cutoff
5. If the patient has insufficient data to classify into one of these categories, the patient must be excluded from the study as they cannot be classified as ACO or non-ACO. For example, patients with extremely high troponin but no culprit seen on cath may have acute occlusion with complete autolysis of thrombus, myocarditis, spasm, etc. Thus the investigators cannot classify them as NO ACO when the possibility of ACO remains and cannot be disproven. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction
How long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria
Measured: 1 year
Secondary outcomes (3)
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria
The difference in sensitivity among the occlusive myocardial infarction cohort for experts versus STEMI criteria
Measured: 1 year
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients
Measured: 1 year
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in patients with widened QRS
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in patients with widened QRS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 May 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Responsible party
- Sponsor
- Investigators
- Stephen W Smith, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863327
- Sponsor's protocol ID
- 1173733-2
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dawkins K, Busk M, Sorensen J, Mortensen LS, Maynard C, Stinnett SS, Wagner GS, Andersen HR; DANAMI-2 investigators. Association between ST segment Resolution following Fibrinolytic therapy or Intracoronary stenting, and Reinfarction in the same myocardial region in the DANAMI-2 study population. Cardiovasc Revasc Med. 2011 Mar-Apr;12(2):75-81. doi: 10.1016/j.carrev.2010.04.003. Epub 2010 Oct 20.
PubMed 21421184O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
PubMed 23256914Jaffe AS. Third universal definition of myocardial infarction. Clin Biochem. 2013 Jan;46(1-2):1-4. doi: 10.1016/j.clinbiochem.2012.10.036. Epub 2012 Nov 2. No abstract available.
PubMed 23127386Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95. doi: 10.1016/j.jacc.2007.09.011. No abstract available.
PubMed 18036459Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EKG Criteria and Identification of Acute Coronary Occlusion
- ClinicalTrials.gov ID
- NCT03863327
- Acronym / sponsor ID
- 1173733-2
- Conditions
- Acute Coronary Syndrome, STEMI, STEMI - ST Elevation Myocardial Infarction, Acute Coronary Artery Thrombosis (Diagnosis), NSTEMI - Non-ST Segment Elevation MI, Non-ST Elevation Myocardial Infarction
- Keywords
- Acute Coronary Occlusion, ACO, Occlusive Myocardial Infarction, OMI, Non-occlusive Myocardial Infarction, NOMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Study start
- 1 May 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart).
The primary analysis will be designed as a multi-center, retrospective case-control study.
Detailed description
In this retrospective, 2-center, case-control study the investigators will investigate and compare the accuracy of various ECG criteria and expert interpretation to diagnose Acute Coronary Occlusion (ACO), with an emphasis on the diagnosis of patients with ACO but without obvious ST segment Elevation Myocardial Infarction (STEMI) criteria. The investigators will use two cohorts of patients who present with symptoms consistent with acute MI, one subsequently proven to have ACO and one proven to not have ACO.
The groups will be identified by chart reviewers who will use all clinical data except the ECGs to determine, in retrospect, and using strict criteria, if the patient had ACO at the time of the ECGs to be evaluated, or not. These reviewers will be blinded to all ECGs. The diagnosis of ACO will be dependent upon angiographic occlusion. Because in many cases of ACO, the artery spontaneously opens by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit on the angiogram PLUS a very elevated peak troponin, as peak troponin I > 10.0 ng/mL and peak troponin T > 1.0 ng/mL are highly correlated with ACO.
The investigators will find cases of subtle STEMI (ACO without STEMI criteria) by searching for all myocardial infarction cases that underwent angiography and percutaneous coronary intervention (PCI). The investigators will attempt by various criteria to determine from all available sources other than the ECG (angiography, echo, troponins) whether the involved artery was occluded at the time of the most diagnostic ECG that was recorded while the patient had symptoms and before the angiogram. Reviewers determining ACO or not ACO will be blinded to the ECGs. The investigators will use each pre-angiogram ECG, in sequence, for analysis, to determine if expert interpretation can not only identify occlusion that is not identified by STEMI criteria, but also to find if expert interpretation can identify occlusion on an earlier ECG. Expert ECG interpreters will interpret the ECG for evidence of ACO. Their accuracy will be compared to traditional STEMI criteria and other methods of interpretation if available.
The investigators will use as controls patients with any ST elevation, or ST depression, of any etiology that are proven to NOT have occlusion. The investigators will establish absence of occlusion by a combination of objective data points including angiogram (if performed), troponins, echocardiograms, clinical course, etc. Details of the methods are below, including specific outcome definitions used to claim the presence or absence of ACO.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Occlusion or near-occlusion (TIMI 0-1) | – | Other: No interventiona. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-1 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI > 10 ng/mL or cTnT > 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis. |
| Acute Coronary Occlusion or near-occlusion (TIMI 0-2) | – | Other: No interventiona. Acute occlusion proven on angiogram (an acute culprit lesion with TIMI 0-2 flow, or description of acute total thrombotic occlusion) b. Acute culprit lesion (any TIMI score) with Peak cTNI > 10 ng/mL or cTnT > 1.0 ng/mL c. If no catheterization performed (contraindicated, not compatible with goals of care, etc), then highly elevated troponin as above plus a new/presumed new focal wall motion abnormality on echocardiography d. Positive ECG findings (by any criteria) with death occurring before attempted emergent coronary angiography and autopsy confirming ACO. For cases with positive ECG findings and death before cath but NO autopsy, these will be marked and saved in a separate group, not to be used in the primary analysis. |
| Acute severe 3-vessel disease or critical left main stenosis | – | Other: No intervention1. Severe 3-vessel disease: >/=75% stenosis in all three major coronary vessels (or equivalents in the case of anatomic variants or preexisting bypass) with an acute culprit lesion (TIMI<3) or 2. Left main stenosis > 50% (see Smith review paper for reference): acute left main culprit of any TIMI score, or any lesion of the left main with TIMI<3 or 3. Any other cardiac catheterization findings prompting initiation of emergent coronary artery bypass grafting within the next 120 hours |
| No evidence of acute coronary occlusion | – | Other: No intervention1. At least three sequential negative cardiac biomarkers within 24 hours of presentation 2. cardiac catheterization showing no culprit lesion. 3. Angiogram showing an acute culprit lesion but both no occlusion (TIMI 2 or greater) and troponins not exceeding the cutoff above 4. If positive troponin values present but no angiography, then the patient must have echocardiography showing no wall motion abnormality and troponin values less than the above cutoff 5. If the patient has insufficient data to classify into one of these categories, the patient must be excluded from the study as they cannot be classified as ACO or non-ACO. For example, patients with extremely high troponin but no culprit seen on cath may have acute occlusion with complete autolysis of thrombus, myocarditis, spasm, etc. Thus the investigators cannot classify them as NO ACO when the possibility of ACO remains and cannot be disproven. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators plan to review and include all individuals that underwent urgent or emergent cardiac catheterization over the course of one year (January 1, 2017 - December 31, 2017).
Key inclusion criteria (1 listed)
- Recorded EKG prior to cardiac catheterization
Key exclusion criteria (1 listed)
- Absence of documented EKG prior to cardiac catheterization
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 |
|---|---|---|
| No interventionThere will be no intervention as a part of this protocol. | Other | Acute Coronary Occlusion or near-occlusion (TIMI 0-1), Acute Coronary Occlusion or near-occlusion (TIMI 0-2), Acute severe 3-vessel disease or critical left main stenosis, No evidence of acute coronary occlusion |
Primary outcome
The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction
Time frame: 1 year
How long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria
3 secondary outcomes
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria
Time frame: 1 year
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients
Time frame: 1 year
The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in patients with widened QRS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Results publication: PubMed 21421184Dawkins K, Busk M, Sorensen J, Mortensen LS, Maynard C, Stinnett SS, Wagner GS, Andersen HR; DANAMI-2 investigators. Association between ST segment Resolution following Fibrinolytic therapy or Intracoronary stenting, and Reinfarction in the same myocardial region in the DANAMI-2 study population. Cardiovasc Revasc Med. 2011 Mar-Apr;12(2):75-81. doi: 10.1016/j.carrev.2010.04.003. Epub 2010 Oct 20.
- Results publication: PubMed 23256914O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
- Results publication: PubMed 23127386Jaffe AS. Third universal definition of myocardial infarction. Clin Biochem. 2013 Jan;46(1-2):1-4. doi: 10.1016/j.clinbiochem.2012.10.036. Epub 2012 Nov 2. No abstract available.
- Results publication: PubMed 18036459Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95. doi: 10.1016/j.jacc.2007.09.011. No abstract available.
- Results publication: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Individual participant dataSharing planned: Undecided
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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.
Stephen W Smith, MD principal investigator
Hennepin County Medical Center, Minneapolis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and STEMI, run by Stony Brook University at 2 sites in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harvey P Meyers, MD (631-793-2148, harvey.meyers@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction (time frame: 1 year). 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 NCT03863327, which also lists 5 linked publications.
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 5 Mar 2019.