ECG Methods for the Prompt Identification of Coronary Events (EMPIRE)

August 14, 2024 updated by: Salah Shafiq Al-Zaiti, University of Pittsburgh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The proposed study is a prospective observational cohort study that will include consecutive patients in Pittsburgh, PA who call 9-1-1 with a chief complaint of chest pain.

Description

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.

Exclusion Criteria:

  • (1) those with traumatic chest pain; (2) those arriving at the ED by private means without prehospital ECG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute Coronary Syndrome (ACS)
Time Frame: 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.
within 30 days of indexed admission
Major Adverse Cardiac Events (MACE)
Time Frame: Within 30 days of indexed admission
A composite endpoint of 1) all-cause death, 2) resuscitated or fatal cardiac arrest; 3) post-admission pulmonary embolus; 4) ventricular arrhythmia; 5) cardiogenic shock; and 6) acute heart failure (new) or acute exacerbation of chronic heart failure.
Within 30 days of indexed admission
Occlusion Myocardial Infarction (OMI)
Time Frame: during index admission
Coronary angiographic evidence of an acute culprit lesion in at least one of the three main coronary arteries (left anterior descending, left circumflex, right coronary artery) or their primary branches with TIMI flow grade of 0-1. TIMI flow grade of 2 with significant coronary narrowing > 70% and peak troponin of 5-10.0 ng/mL is also considered indicative of OMI.
during index admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular Death
Time Frame: 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.
Within 30 days of indexed admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salah s Al-Zaiti, RN, PhD, Univ of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19060239
  • R01HL137761 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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