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Cited by 141Cardiac Imaging and DiagnosticsCoronary Interventions and DiagnosticsAcute Myocardial Infarction Research

PROspective Multicenter Imaging Study for Evaluation of chest pain: Rationale and design of the PROMISE trial

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Douglas, Pamela S., Hoffmann, Udo, Lee, Kerry L., Mark, Daniel B., Al-Khalidi, Hussein R., Anstrom, Kevin, Dolor, Rowena J., Kosinski, Andrzej +7 more·2014·American Heart Journal
DOI 10.1016/j.ahj.2014.03.003PMC PMC4044617
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Abstract

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.

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  • In PROMISE, there was a graded association between extent of deep learning calcium score and cardiac events, defined as the composite of death, myocardial infarction, or hospitalization for unstable angina over median 25 months (P < 0.001).

    “In 4021 patients acquired at 193 North American sites, there was a graded association between extent of deep learning calcium score and cardiac events, defined as the composite of death, myocardial infarction, or hospitalization for unstable angina over median 25 months (P < 0.001)(Fig. 2b)19.”

    From Deep convolutional neural networks to predict cardiovascular risk from computed tomography (2021) · cites this paper as [19]

    The Abstract Results reports enrollment at 193 US and Canadian sites, and the Abstract Methods identifies death, myocardial infarction, and hospitalization for unstable angina as components of the planned endpoint. But this rationale-and-design paper does not report an analysis of 4,021 patients, deep-learning calcium scores, a graded association with events, median 25-month follow-up, or P < 0.001. Its planned primary endpoint also includes major procedural complications, which the cited sentence omits. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • Risk prediction was robust across multiple clinical scenarios, including a primary prevention asymptomatic setting with non-gated chest CT, and dedicated ECG-gated cardiac CT in stable and acute chest pain settings.

    “Risk prediction was robust across multiple clinical scenarios, including a primary prevention asymptomatic setting with non-gated chest CT (NLST)18, as well as dedicated ECG-gated cardiac CT in stable (PROMISE)19 and acute (ROMICAT-II)20 chest pain setting.”

    From Deep convolutional neural networks to predict cardiovascular risk from computed tomography (2021) · cites this paper as [19]

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Authors
Douglas, P. S., Hoffmann, U., Lee, K. L., Mark, D. B., Al-Khalidi, H. R., Anstrom, K., Dolor, R. J., Kosinski, A., Krucoff, M. W., Mudrick, D. W., Patel, M. R., Picard, M. H., Udelson, J. E., Velazquez, E. J., & Cooper, L.
Affiliations
  • Duke University (US)
  • Harvard University (US)
  • Tufts University (US)
  • National Heart, Lung, and Blood Institute (US)
Corresponding author
Douglas, Pamela S.
ORCID
Venue
American Heart Journal
Publisher
Elsevier BV
Published
2014-06
Volume
167
Issue
6
Pages
796-803.e1
ISSN
0002-8703 (ISSN-L)
DOI
10.1016/j.ahj.2014.03.003
PMC
PMC4044617
OpenAlex
W1984973071
Cited by
141
References
2
Citations by year
2026: 10 · 2025: 13 · 2024: 11 · 2023: 10 · 2022: 10 · 2021: 12 · 2020: 11 · 2019: 11 · 2018: 8 · 2017: 12 · 2016: 20 · 2015: 10 · 2014: 2 · 2012: 1
FWCI
11.48
Type
journal article
Language
en
Open access
Licence
Locations
  • American Heart Journal (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Funders
  • National Institutes of Health (5t32hl069749-20, UL1TR000439)
  • National Heart, Lung, and Blood Institute (T32-HL069749, R01HL098237, K24HL113128, R01HL098235, R01HL098305, R01HL098236)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiac Imaging and Diagnostics
  • Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Keywords
PROMISE trial, coronary artery disease, chest pain, exercise electrocardiography, stress echocardiography, myocardial infarction, unstable angina, radiation exposure, cost-effectiveness
MeSH terms
Aged, Chest Pain, Coronary Artery Disease, Cost-Benefit Analysis, Electrocardiography, Exercise Test, Female, Heart, Humans, Male, Middle Aged, Quality of Life, Coronary Angiography, Health Care Costs, Echocardiography, Stress, Myocardial Perfusion Imaging, Multidetector Computed Tomography

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