Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain

Jeffrey M. Levsky, Mark I. Travin, Daniel M. Spevack, Mark A. Menegus, Paul W. Huang, Ythan Goldberg, Elana T. Clark, Prameela Banoth, Katherine D. Freeman, Jonathan N. Tobin, Linda B. Haramati

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: Noninvasive cardiac imaging plays an important role in the diagnosis and management of coronary artery disease (CAD). Prior studies have focused on the diagnostic performance of noninvasive modalities using angiographically significant stenoses as the reference standard. Recent trends in evidence-based medicine and increasing imaging utilization call for validation of diagnostic algorithms with well-designed, controlled trials with clinical outcome endpoints. Objective: To compare the performance of stress radionuclide myocardial perfusion imaging (MPI) and coronary computed tomography angiography (CTA) in terms of outcomes. Methods: We designed a single-center, randomized controlled trial that compares MPI and CTA as the initial modality for the evaluation of patients hospitalized for chest pain without known CAD or acute myocardial infarction. Patients with intermediate-risk characteristics and a clinical need for noninvasive imaging are included. The primary outcome measured is the incidence of conventional angiography not leading to subsequent coronary revascularization within 1 year. The study is powered to detect a reduction from 11% to 3% in catheterization not leading to an intervention with a sample size of 400. Secondary outcomes include procedural complications and posttest renal dysfunction (safety outcomes), major adverse cardiovascular events, length of hospital stay, subsequent hospitalizations and imaging, changes in medical management, and tolerability of the noninvasive test. Conclusions: The results of this trial will further our understanding of the relative appropriateness of CTA and MPI in evaluating intermediate-risk patients hospitalized with chest pain. It will also have implications for the design and probability of success of multicentered trials that are currently being planned.

Original languageEnglish (US)
Pages (from-to)264-271
Number of pages8
JournalJournal of Cardiovascular Computed Tomography
Volume3
Issue number4
DOIs
StatePublished - Jul 2009

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Myocardial Perfusion Imaging
Coronary Angiography
Chest Pain
Randomized Controlled Trials
Coronary Artery Disease
Length of Stay
Evidence-Based Medicine
Controlled Clinical Trials
Catheterization
Radioisotopes
Sample Size
Angiography
Pathologic Constriction
Hospitalization
Myocardial Infarction
Kidney
Safety
Incidence
Computed Tomography Angiography

Keywords

  • Conventional angiography
  • Coronary computed tomography angiography
  • Coronary revascularization
  • Randomized controlled trial
  • Stress myocardial perfusion imaging

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

@article{568320b71c2943f7b511e3d8158892a1,
title = "Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain",
abstract = "Background: Noninvasive cardiac imaging plays an important role in the diagnosis and management of coronary artery disease (CAD). Prior studies have focused on the diagnostic performance of noninvasive modalities using angiographically significant stenoses as the reference standard. Recent trends in evidence-based medicine and increasing imaging utilization call for validation of diagnostic algorithms with well-designed, controlled trials with clinical outcome endpoints. Objective: To compare the performance of stress radionuclide myocardial perfusion imaging (MPI) and coronary computed tomography angiography (CTA) in terms of outcomes. Methods: We designed a single-center, randomized controlled trial that compares MPI and CTA as the initial modality for the evaluation of patients hospitalized for chest pain without known CAD or acute myocardial infarction. Patients with intermediate-risk characteristics and a clinical need for noninvasive imaging are included. The primary outcome measured is the incidence of conventional angiography not leading to subsequent coronary revascularization within 1 year. The study is powered to detect a reduction from 11{\%} to 3{\%} in catheterization not leading to an intervention with a sample size of 400. Secondary outcomes include procedural complications and posttest renal dysfunction (safety outcomes), major adverse cardiovascular events, length of hospital stay, subsequent hospitalizations and imaging, changes in medical management, and tolerability of the noninvasive test. Conclusions: The results of this trial will further our understanding of the relative appropriateness of CTA and MPI in evaluating intermediate-risk patients hospitalized with chest pain. It will also have implications for the design and probability of success of multicentered trials that are currently being planned.",
keywords = "Conventional angiography, Coronary computed tomography angiography, Coronary revascularization, Randomized controlled trial, Stress myocardial perfusion imaging",
author = "Levsky, {Jeffrey M.} and Travin, {Mark I.} and Spevack, {Daniel M.} and Menegus, {Mark A.} and Huang, {Paul W.} and Ythan Goldberg and Clark, {Elana T.} and Prameela Banoth and Freeman, {Katherine D.} and Tobin, {Jonathan N.} and Haramati, {Linda B.}",
year = "2009",
month = "7",
doi = "10.1016/j.jcct.2009.05.006",
language = "English (US)",
volume = "3",
pages = "264--271",
journal = "Journal of Cardiovascular Computed Tomography",
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TY - JOUR

T1 - Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain

AU - Levsky, Jeffrey M.

AU - Travin, Mark I.

AU - Spevack, Daniel M.

AU - Menegus, Mark A.

AU - Huang, Paul W.

AU - Goldberg, Ythan

AU - Clark, Elana T.

AU - Banoth, Prameela

AU - Freeman, Katherine D.

AU - Tobin, Jonathan N.

AU - Haramati, Linda B.

PY - 2009/7

Y1 - 2009/7

N2 - Background: Noninvasive cardiac imaging plays an important role in the diagnosis and management of coronary artery disease (CAD). Prior studies have focused on the diagnostic performance of noninvasive modalities using angiographically significant stenoses as the reference standard. Recent trends in evidence-based medicine and increasing imaging utilization call for validation of diagnostic algorithms with well-designed, controlled trials with clinical outcome endpoints. Objective: To compare the performance of stress radionuclide myocardial perfusion imaging (MPI) and coronary computed tomography angiography (CTA) in terms of outcomes. Methods: We designed a single-center, randomized controlled trial that compares MPI and CTA as the initial modality for the evaluation of patients hospitalized for chest pain without known CAD or acute myocardial infarction. Patients with intermediate-risk characteristics and a clinical need for noninvasive imaging are included. The primary outcome measured is the incidence of conventional angiography not leading to subsequent coronary revascularization within 1 year. The study is powered to detect a reduction from 11% to 3% in catheterization not leading to an intervention with a sample size of 400. Secondary outcomes include procedural complications and posttest renal dysfunction (safety outcomes), major adverse cardiovascular events, length of hospital stay, subsequent hospitalizations and imaging, changes in medical management, and tolerability of the noninvasive test. Conclusions: The results of this trial will further our understanding of the relative appropriateness of CTA and MPI in evaluating intermediate-risk patients hospitalized with chest pain. It will also have implications for the design and probability of success of multicentered trials that are currently being planned.

AB - Background: Noninvasive cardiac imaging plays an important role in the diagnosis and management of coronary artery disease (CAD). Prior studies have focused on the diagnostic performance of noninvasive modalities using angiographically significant stenoses as the reference standard. Recent trends in evidence-based medicine and increasing imaging utilization call for validation of diagnostic algorithms with well-designed, controlled trials with clinical outcome endpoints. Objective: To compare the performance of stress radionuclide myocardial perfusion imaging (MPI) and coronary computed tomography angiography (CTA) in terms of outcomes. Methods: We designed a single-center, randomized controlled trial that compares MPI and CTA as the initial modality for the evaluation of patients hospitalized for chest pain without known CAD or acute myocardial infarction. Patients with intermediate-risk characteristics and a clinical need for noninvasive imaging are included. The primary outcome measured is the incidence of conventional angiography not leading to subsequent coronary revascularization within 1 year. The study is powered to detect a reduction from 11% to 3% in catheterization not leading to an intervention with a sample size of 400. Secondary outcomes include procedural complications and posttest renal dysfunction (safety outcomes), major adverse cardiovascular events, length of hospital stay, subsequent hospitalizations and imaging, changes in medical management, and tolerability of the noninvasive test. Conclusions: The results of this trial will further our understanding of the relative appropriateness of CTA and MPI in evaluating intermediate-risk patients hospitalized with chest pain. It will also have implications for the design and probability of success of multicentered trials that are currently being planned.

KW - Conventional angiography

KW - Coronary computed tomography angiography

KW - Coronary revascularization

KW - Randomized controlled trial

KW - Stress myocardial perfusion imaging

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