Are Serial Electrocardiograms Additive to SeriAl Second-generations Troponins in Predicting Acute CoronAry Syndromes in PatienTs With Undifferentiated cHest Pain (ASAP Cath)

February 16, 2022 updated by: Wake Forest University Health Sciences

Are Serial Electrocardiograms Additive to SeriAl Second-generations Troponins in Predicting Acute CoronAry Syndromes in PatienTs With Undifferentiated cHest Pain (ASAP CATH) Study

Our research will examine whether the presence or absence of serial electrocardiogram (ECG) changes aids in reclassifying participants' risk for major adverse cardiac events (MACE) over and above serial blood testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chest pain is one of the most common symptoms evaluated in the Emergency Department (ED). One of the primary diagnostic concerns during the evaluation of this presentation is whether there is evidence of acute coronary syndromes (ACS) as ACS is a major risk factor for short- and long-term major adverse cardiovascular events (MACE, defined as acute myocardial infarction, revascularization, or all-cause death). Two of the cornerstones of the guidelines-based evaluation of this patient group are serial electrocardiograms (ECG) and troponin measurements (a serological marker of myocardial ischemia), which have shown to be both independently and incrementally predictive of ACS. Recently, second-generation troponin assays have been adopted into clinical practice as they have higher sensitivity and specificity for ACS compared to older assays. Given the increased diagnostic accuracy of these novel second-generation assays, the proposed study's research question is to investigate whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin changes in predicting MACE in patients presenting with symptoms consistent with ACS. In order to investigate this question, we originally proposed an observational pilot study ancillary to the HEART Pathway trial (WFUHS IRB00021074), a funded randomized controlled trial investigating a recently developed decision aid tool (the HEART score) designed to identify patients being evaluated for chest pain that can safely forgo further objective testing. We proposed to add the collection of two additional 12-lead ECGs to the protocol in the HEART Pathway trial, which included serial second-generation troponin collection, in order to generate pilot data regarding the research question. As recruitment for the HEART Pathway trial ended in February 2014, we now propose to continue enrollment for the ASAP CATH study independently, as a prospective observational study evaluating the additional prognostic value of serial ECGs to standard care in patients with chest pain being evaluated for acute coronary syndromes in the Emergency Department.

Objective:

The goal of this project is to produce preliminary data to investigate whether the presence or absence of serial ECG changes suggestive of myocardial ischemia aids in reclassifying participants' risk for MACE and objective evidence of ACS over and above serial second-generation troponin testing.

Methods:

Adult patients, over 21 years old, presenting to WFBMC ED with chest pain or symptoms concerning for ACS, in which the provider orders cardiac biomarkers and an ECG will be eligible for enrollment. We aim to add serial ECG analysis (one at the time of study enrollment and a second at the time of the study blood draw) to the protocol in the proposed study. The primary outcomes are major adverse cardiovascular events (MACE) at 30 days and evidence of acute myocardial ischemia via objective cardiac testing performed during the index hospitalization.

Study Type

Observational

Enrollment (Anticipated)

382

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center - Emergency Department

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

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the Wake Forest Baptist Health Emergency Department with symptoms concerning for Acute Coronary Syndrome (ACS) are eligible for enrollment.

Description

Inclusion Criteria:

  • Age greater than or equal to 21 years of age at the time of enrollment
  • Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded

Exclusion Criteria:

  • Evidence of ST-elevation myocardial infarction (STEMI) or left bundle branch block (LBBB) on initial ECG
  • Left ventricular systolic dysfunction (history of left ventricular ejection fraction <40% or active symptoms of congestive heart failure)
  • New or uncontrolled ventricular arrhythmias on initial ECG
  • Hemodynamic instability: heart rate > 120 bpm or < 40 bpm and/or systolic blood pressure <100 mmHg
  • Hypoxemia (oxygen saturation <90% on room air or normal home oxygen flow rate)
  • Terminal diagnosis with life expectancy less than 1 year
  • A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing.
  • Prior enrollment
  • Incapacity or unwillingness to provide consent and comply with study procedures

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serial Electrocardiogram Arm
All study participants will receive serial electrocardiograms.
Device: Serial Electrocardiograms
All participants will have serial electrocardiograms performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events at 30 days
Time Frame: 30 Days
Determine whether serial electrocardiogram changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting MACE at 30 days in patients with symptoms suggestive of ACS.
30 Days
Evidence of acute myocardial ischemia via objective cardiac testing performed during the index hospitalization
Time Frame: Duration of initial hospitalization, usually 1 to 2 days
Determine whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting positive cardiac stress testing or coronary angiography findings indicative of acute myocardial ischemia in patients being evaluated for ACS.
Duration of initial hospitalization, usually 1 to 2 days
Major Adverse Cardiovascular Events at 30 days
Time Frame: 30 Days
Determine whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting major adverse cardiovascular events at 30 days in patients with symptoms suggestive of ACS.
30 Days

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

American Heart Association

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)

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

January 15, 2018

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (ESTIMATE)

September 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00022288

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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