PROspective Multicenter Imaging Study for Evaluation of chest pain: Rationale and design of the PROMISE trial
Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a p...
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| Published in | The American heart journal Vol. 167; no. 6; pp. 796 - 803.e1 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Mosby, Inc
01.06.2014
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0002-8703 1097-6744 1097-6744 |
| DOI | 10.1016/j.ahj.2014.03.003 |
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| Abstract | Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients.
The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina.
More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites.
Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. |
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| AbstractList | Background Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. Results More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Conclusion Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Background Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with >=64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for >=1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. Results More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Conclusion Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients.BACKGROUNDSuspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients.The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina.METHODSThe PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina.More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites.RESULTSMore than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites.Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed.CONCLUSIONMultispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. |
| Author | Al-Khalidi, Hussein R. Velazquez, Eric J. Anstrom, Kevin Cooper, Lawton Douglas, Pamela S. Hoffmann, Udo Mudrick, Daniel W. Dolor, Rowena J. Krucoff, Mitchell W. Lee, Kerry L. Mark, Daniel B. Patel, Manesh R. Kosinski, Andrzej Picard, Michael H. Udelson, James E. |
| AuthorAffiliation | 4 Tufts Medical Center and Tufts University School of Medicine 3 McConnell Heart Health Center, Columbus, OH 1 Duke Clinical Research Institute, Duke University School of Medicine 2 Massachusetts General Hospital, Harvard Medical School 5 National Heart, Lung, and Blood Institute |
| AuthorAffiliation_xml | – name: 4 Tufts Medical Center and Tufts University School of Medicine – name: 5 National Heart, Lung, and Blood Institute – name: 1 Duke Clinical Research Institute, Duke University School of Medicine – name: 2 Massachusetts General Hospital, Harvard Medical School – name: 3 McConnell Heart Health Center, Columbus, OH |
| Author_xml | – sequence: 1 givenname: Pamela S. surname: Douglas fullname: Douglas, Pamela S. email: pamela.douglas@duke.edu organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 2 givenname: Udo surname: Hoffmann fullname: Hoffmann, Udo organization: Massachusetts General Hospital, Harvard Medical School, Columbus, OH – sequence: 3 givenname: Kerry L. surname: Lee fullname: Lee, Kerry L. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 4 givenname: Daniel B. surname: Mark fullname: Mark, Daniel B. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 5 givenname: Hussein R. surname: Al-Khalidi fullname: Al-Khalidi, Hussein R. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 6 givenname: Kevin surname: Anstrom fullname: Anstrom, Kevin organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 7 givenname: Rowena J. surname: Dolor fullname: Dolor, Rowena J. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 8 givenname: Andrzej surname: Kosinski fullname: Kosinski, Andrzej organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 9 givenname: Mitchell W. surname: Krucoff fullname: Krucoff, Mitchell W. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 10 givenname: Daniel W. surname: Mudrick fullname: Mudrick, Daniel W. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 11 givenname: Manesh R. surname: Patel fullname: Patel, Manesh R. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 12 givenname: Michael H. surname: Picard fullname: Picard, Michael H. organization: Massachusetts General Hospital, Harvard Medical School, Columbus, OH – sequence: 13 givenname: James E. surname: Udelson fullname: Udelson, James E. organization: Tufts Medical Center, Tufts University School of Medicine, Boston, MA – sequence: 14 givenname: Eric J. surname: Velazquez fullname: Velazquez, Eric J. organization: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH – sequence: 15 givenname: Lawton surname: Cooper fullname: Cooper, Lawton organization: National Heart, Lung, and Blood Institute, Bethesda, MD |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24890527$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Apgar, Charles Cooper, Lawton Udelson, James E Cook, Nakela Hoffmann, Udo Schneider, Ricky Bertoni, Alain Go, Alan Velazquez, Eric J Dolor, Rowena J Mudrick, Daniel W Picard, Michael H Vavalle, John Leifer, Eric Picard, Michael Rubin, Geoffrey Salvaggio, Kristen Mark, Daniel Hayden, Sarah Harding, Tina Bonds, Denise Ulrich, Connie M Min, James K Spertus, John A Tardif, Jean Claude Ghoshhajra, Brian B Carr, J Jeffrey Anderson, Garnet Proschan, Michael Al-Khalidi, Hussein R Bonow, Robert Shen, Alexandra Kosinski, Andrzej Douglas, Pamela S Krucoff, Mitchell W Patel, Manesh R Truong, Quynh Achenbach, Stephan Corsini, Erin Lee, Kerry |
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| Copyright | 2014 Mosby, Inc. Mosby, Inc. Copyright © 2014 Mosby, Inc. All rights reserved. Copyright Elsevier Limited Jun 2014 2014 Mosby, Inc. All rights reserved. 2014 |
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| DOI | 10.1016/j.ahj.2014.03.003 |
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| Snippet | Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large... Background Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However,... |
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| SubjectTerms | Accuracy Aged Cardiovascular Cardiovascular disease Chest Pain - etiology Coronary Angiography - economics Coronary Angiography - methods Coronary Artery Disease - complications Coronary Artery Disease - diagnosis Cost-Benefit Analysis Costs Echocardiography, Stress - economics Echocardiography, Stress - methods Electrocardiography - economics Electrocardiography - methods Exercise Test - economics Exercise Test - methods Female Health Care Costs Heart - diagnostic imaging Heart attacks Humans Hypotheses Intubation Male Medical imaging Middle Aged Multidetector Computed Tomography - economics Multidetector Computed Tomography - methods Myocardial Perfusion Imaging - economics Myocardial Perfusion Imaging - methods Pragmatism Quality of Life |
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| Title | PROspective Multicenter Imaging Study for Evaluation of chest pain: Rationale and design of the PROMISE trial |
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