Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT03863327

Conditions

Acute Coronary Syndrome

STEMI

STEMI - ST Elevation Myocardial Infarction

Acute Coronary Artery Thrombosis (Diagnosis)

NSTEMI - Non-ST Segment Elevation MI

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief 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). 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.

Conditions

Acute Coronary Syndrome

STEMI

STEMI - ST Elevation Myocardial Infarction

Acute Coronary Artery Thrombosis (Diagnosis)

NSTEMI - Non-ST Segment Elevation MI

Study ID

NCT03863327

Start date

May 1, 2018

Status verified date

Mar, 2019

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recorded EKG prior to cardiac catheterization

Exclusion Criteria:

  • Absence of documented EKG prior to cardiac catheterization

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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

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.

Interventions

No intervention

There will be no intervention as a part of this protocol.

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 ]

Central Contacts and Locations

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Principal Investigator:

Stephen W Smith, MD

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

Adam J Singer, MD

More Information

Sponsor

Stony Brook University

Last update posted

Mar 5, 2019

Last verified

Mar, 2019

Keywords

  • Acute Coronary Occlusion
  • ACO
  • Occlusive Myocardial Infarction
  • OMI
  • Non-occlusive Myocardial Infarction
  • NOMI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2019-03-05.