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Chest PainEMPIRENCT04237688

ECG Methods for the Prompt Identification of Coronary Events

An observational study of Chest Pain and Myocardial Infarction, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
6,000 participants
Where
1 siteUnited States
Study dates
1 May 2013to 31 Dec 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • (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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
electrocardiogram
Medical subject headings
Chest Pain, Myocardial Infarction, Myocardial Ischemia, Acute Coronary Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Coronary Syndrome (ACS)

    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.

    Measured: within 30 days of indexed admission

  2. Occlusion Myocardial Infarction (OMI)

    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.

    Measured: during index admission

  3. Major Adverse Cardiac Events (MACE)

    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.

    Measured: Within 30 days of indexed admission

Secondary outcomes (1)

  1. Cardiovascular Death

    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.

    Measured: Within 30 days of indexed admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start1 May 2013
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04237688
Sponsor's protocol ID
STUDY19060239
Other IDs
R01HL137761
Acronym
EMPIRE
Status last verified
Aug 2024
First submitted
17 Jan 2020
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bouzid Z, Faramand Z, Martin-Gill C, Sereika SM, Callaway CW, Saba S, Gregg R, Badilini F, Sejdic E, Al-Zaiti SS. Incorporation of Serial 12-Lead Electrocardiogram With Machine Learning to Augment the Out-of-Hospital Diagnosis of Non-ST Elevation Acute Coronary Syndrome. Ann Emerg Med. 2023 Jan;81(1):57-69. doi: 10.1016/j.annemergmed.2022.08.005. Epub 2022 Oct 15.

    PubMed 36253296

  • Faramand Z, Helman S, Ahmad A, Martin-Gill C, Callaway C, Saba S, Gregg RE, Wang J, Al-Zaiti S. Performance and limitations of automated ECG interpretation statements in patients with suspected acute coronary syndrome. J Electrocardiol. 2021 Nov-Dec;69S:45-50. doi: 10.1016/j.jelectrocard.2021.08.014. Epub 2021 Aug 18.

    PubMed 34465465

  • Faramand Z, Martin-Gill C, Callaway C, Al-Zaiti S. Modified HEART score to optimize risk stratification in cocaine-associated chest pain. Am J Emerg Med. 2021 Sep;47:307-308. doi: 10.1016/j.ajem.2021.01.023. Epub 2021 Jan 15. No abstract available.

    PubMed 33494961

  • Bouzid Z, Faramand Z, Gregg RE, Frisch SO, Martin-Gill C, Saba S, Callaway C, Sejdic E, Al-Zaiti S. In Search of an Optimal Subset of ECG Features to Augment the Diagnosis of Acute Coronary Syndrome at the Emergency Department. J Am Heart Assoc. 2021 Feb 2;10(3):e017871. doi: 10.1161/JAHA.120.017871. Epub 2021 Jan 17.

    PubMed 33459029

Questions about this trial

What is this clinical trial studying?

An observational study of Chest Pain and Myocardial Infarction, run by University of Pittsburgh at 1 site 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: finished, as of the sponsor's last update on 16 Aug 2024. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Acute Coronary Syndrome (ACS) (time frame: within 30 days of indexed admission). The study lists 3 primary outcomes in all. 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 NCT04237688, which also lists 4 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 16 Aug 2024.

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