ECG Methods for the Prompt Identification of Coronary Events

NCT04237688 | Completed

• 2 other identifiers: STUDY19060239R01HL137761
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Myocardial Infarction; Myocardial Ischemia; Acute Coronary Syndrome

Keywords

electrocardiogram

Outcome Measures

Primary Outcomes (3)

• 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.

  within 30 days of indexed admission

• 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.

  during index admission

• 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.

  Within 30 days of indexed admission

Secondary Outcomes (1)

• Cardiovascular Death

  Within 30 days of indexed admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 36253296 DERIVED

• 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.

  PMID: 34465465 DERIVED

• 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.

  PMID: 33494961 DERIVED

• 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.

  PMID: 33459029 DERIVED

MeSH Terms

Conditions

Chest Pain; Myocardial Infarction; Myocardial Ischemia; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Salah s Al-Zaiti, RN, PhD

  Univ of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2013
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)