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

NCT01953276 | Completed

• 1 other identifier: IRB00022288
• Study Type: observational
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Chest Pain

Keywords

Acute Coronary Syndrome; Chest pain; Electrocardiograms; Risk Stratification; Emergency Department

Outcome Measures

Primary Outcomes (3)

• Major Adverse Cardiovascular Events at 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

  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

  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

Study Arms (1)

Serial Electrocardiogram Arm

All study participants will receive serial electrocardiograms.

Device: Serial Electrocardiograms

Interventions

Serial Electrocardiograms DEVICE

All participants will have serial electrocardiograms performed.

Serial Electrocardiogram Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Heart Association: collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center - Emergency Department

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (26)

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples are obtained from patients and processed so that the plasma is extracted and frozen for future research.

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Simon Mahler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: January 15, 2018
• Last Updated: February 17, 2022

Record last verified: 2018-02

Locations

US (1)