Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain

Jeffrey M. Levsky, Linda B. Haramati, Cynthia C. Taub, Daniel M. Spevack, Mark A. Menegus, Mark I. Travin, Shayna Vega, Rikah Lerer, Durline Brown-Manhertz, Esther Hirschhorn, Jonathan N. Tobin, Mario J. Garcia

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions. Objective To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease. Design This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28% to 15% with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry. ConclusionsThis RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED.

Original languageEnglish (US)
Pages (from-to)744-750
Number of pages7
JournalEchocardiography
Volume31
Issue number6
DOIs
StatePublished - 2014

Fingerprint

Stress Echocardiography
Coronary Angiography
Chest Pain
Hospital Emergency Service
Comparative Effectiveness Research
Hospitalization
Randomized Controlled Trials
Hospital Costs
Patient Admission
Acute Pain
Random Allocation
Health Expenditures
Sample Size
Registries
Coronary Artery Disease
Length of Stay
Cardiovascular Diseases
Computed Tomography Angiography
Delivery of Health Care
Safety

Keywords

  • chest pain
  • comparative effectiveness research
  • coronary computed tomography angiography
  • emergency department
  • randomized controlled trial
  • stress echocardiography

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

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title = "Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain",
abstract = "Background Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions. Objective To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease. Design This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28{\%} to 15{\%} with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry. ConclusionsThis RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED.",
keywords = "chest pain, comparative effectiveness research, coronary computed tomography angiography, emergency department, randomized controlled trial, stress echocardiography",
author = "Levsky, {Jeffrey M.} and Haramati, {Linda B.} and Taub, {Cynthia C.} and Spevack, {Daniel M.} and Menegus, {Mark A.} and Travin, {Mark I.} and Shayna Vega and Rikah Lerer and Durline Brown-Manhertz and Esther Hirschhorn and Tobin, {Jonathan N.} and Garcia, {Mario J.}",
year = "2014",
doi = "10.1111/echo.12464",
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T1 - Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain

AU - Levsky, Jeffrey M.

AU - Haramati, Linda B.

AU - Taub, Cynthia C.

AU - Spevack, Daniel M.

AU - Menegus, Mark A.

AU - Travin, Mark I.

AU - Vega, Shayna

AU - Lerer, Rikah

AU - Brown-Manhertz, Durline

AU - Hirschhorn, Esther

AU - Tobin, Jonathan N.

AU - Garcia, Mario J.

PY - 2014

Y1 - 2014

N2 - Background Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions. Objective To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease. Design This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28% to 15% with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry. ConclusionsThis RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED.

AB - Background Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions. Objective To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease. Design This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28% to 15% with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry. ConclusionsThis RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED.

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