EMPIRE: ECG Methods for the Prompt Identification of Coronary Events

Sponsor

University of Pittsburgh (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04237688

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

6,000

Enrollment

Location

164

Anticipated Duration (Months)

36.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a clear need to develop improved tools to stratify risk in patients who seek emergency care for chest pain, one of the most common and potentially deadliest conditions encountered in acute care settings. The ECG has been the mainstay of initial evaluation of chest pain patients, yet is currently only diagnostic for a small subset of patients with ST-elevation myocardial infarction. Prior studies have identified candidate markers of ECG characteristics and preliminary algorithms that can identify patients with non-ST elevation myocardial infarction as well as those with very low risk of coronary artery disease. This study will enroll a cohort of consecutive chest pain patients needed to confirm the accuracy of these ECG markers and determine their maximal clinical utility as part of a risk stratification tool. With these improved tools, emergency providers (physicians, nurses, and paramedics) will be able to streamline the care provided to these patients beyond the costly and time-consuming overnight observation for serial cardiac enzymes and provocative testing.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain Myocardial Infarction Myocardial Ischemia Acute Coronary Syndrome

Detailed Description

The disease burden of coronary artery diseases (CAD) remains one of the most serious and persistent health problems for the investigator's nation. One out of every six deaths in the United States is solely attributed to CAD. Every year, nearly 7 million adults visit the emergency department (ED), reporting chest pain associated with a possible heart attack. Being able to immediately differentiate between cardiac (ischemic) and non-cardiac chest pain is crucial and improves survival and reduces disability for thousands of people. The electrocardiogram (ECG) is an indispensable tool to detect ischemia and is the first tool available for initial chest pain evaluation in EDs and, even earlier, by paramedics in the field. Current guidelines focus on ST elevation (STE) to identify patients most in need of immediate treatment. Unfortunately, STE only occurs in one-third of all patients with acute myocardial infarction, and missed myocardial infarction remains one of the highest sources of medical malpractice in emergency medicine. This translates to delayed treatment for nearly 1 million heart attacks until costly, time-consuming, and more invasive diagnostics are conducted and interpreted. Prior work by the investigators has explored novel ECG markers, other than STE, and noted that the dynamic ECG changes in these markers can improve diagnosis of acute coronary syndromes (ACS). This prior data showed that myocardial ischemia disturbs the ventricular repolarization process and results in quantifiable distortions of T waves on the surface 12-lead ECG prior to any displacement of the ST segment. Markers of T wave abnormalities, therefore, can identify patients with ischemic chest pain in the absence of acute ST changes very early in the triage process. The current study plans to evaluate how these novel ischemic ECG changes evolve over time during the acute phase of the coronary syndromes. This approach has a high potential for improving the speed and accuracy of diagnosing ACS and is potentially deployable in any ED or ambulance to greatly accelerate definitive treatment, thereby reducing morbidity and mortality for thousands of patients each year.

Study Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Electrocardiographic Methods for the Prehospital Identification of Non-ST Elevation Myocardial Infarction Events (EMPIRE)

Actual Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Outcome Measures

Primary Outcome Measures

Acute Coronary Syndrome [within 30 days of indexed admission]
The presence of symptoms of ischemia (i.e. diffuse discomfort in the chest, upper extremity, jaw, or epigastric area for more than 20 minutes) and at least one of the following criteria: (1) subsequent development of labile, ischemic ECG changes (e.g., ST changes, T inversion) during hospitalization, (2) elevation of cardiac troponin (i.e., > 99th percentile) during hospital stay, (3) coronary angiography demonstrating greater than 70% stenosis, with or without treatment, and/or (4) functional cardiac evaluation (stress testing) that demonstrates ECG, echocardiographic, or radionuclide evidence of focal cardiac ischemia.
Cardiovascular Death [Within 30 days of indexed admission]
Death within 30 days of initial presentation due to any CV-related etiology ( ICD-9 codes 390-459). Thirty-day re-infarction or life-threatening ventricular arrhythmias (VT/VF) requiring cardioversion will be considered CV-death equivalent. Unexplained deaths occurring within 30 days of indexed event will be considered CV-related.

Secondary Outcome Measures

Major Adverse Cardiac Events (MACE) [Within 30 days of indexed admission]
A composite endpoint of 1) all-cause death, 2) resuscitated or fatal cardiac arrest; 3) acute coronary syndrome; 4) coronary revascularization; 5) post-admission pulmonary embolus; 6) ventricular arrhythmia; 7) cardiogenic shock; and 8) acute heart failure during the indexed hospitalization or within 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

(1) 18 years of age or over; (2) present with a chief complaint of non-traumatic chest pain or other atypical, suspicious symptoms requiring ECG evaluation (e.g., shortness of breath); and (3) arrives at ED by EMS transport with 12-lead ECG already obtained.