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Background <p>This trial aims to assess the effectiveness of a novel diagnostic package in the investigation of symptomatic chronic coronary artery disease (CAD), with a focus on reducing the time to diagnosis and improving risk assessment, compared to the current standard investigation approach. The package investigation is comprised of combined single photon emission computed tomography (SPECT), echocardiography, coronary artery calcification (CAC) scoring, not previously evaluated in Sweden for individual cardiovascular prevention, and CadScore, an acoustic risk score. The standard investigation is comprised of exercise bicycle stress testing and echocardiography.</p> Methods <p>The trial involves patients with a pre-test probability &gt; 15% for significant CAD referred from primary healthcare centers (PHCs) in Region Östergötland (population 471,241 in March 2023) in south-east Sweden. All the 47 PHCs of the region will be invited to participate and will, after approval, be cluster randomized into two groups: package investigation versus standard investigation. The primary outcome is a composite measure comprised of waiting time to invasive coronary angiography or communication of non-invasive myocardial ischemia investigation results. Secondary outcomes include major adverse cardiovascular events (MACE), cost per patient, signs of reversible ischemia on any test, radiation exposure, and adherence to prescribed cardioprotective drugs.</p> Discussion <p>This trial addresses the urgent problem of chest pain and dyspnea assessment in primary care and aims to speed up diagnosis, reduce the need for specialist consultations, and potentially improve patient outcomes, with referral to SPECT directly from PHC in comparison with the widely used exercise test. The novel approach includes CAC scoring. Additionally, the utility of acoustic CadScore in reclassifying the risk of CAD is explored.</p> <p>Trial registration.</p> <p>The trial was registered on March 11, 2023, at ClinicalTrials.gov with the identifier: NCT05782582.</p>

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Chronic cOronary Syndrome in Swedish PRImary care (COSPRI)—a study protocol for a 5-year cluster randomized controlled trial on a novel package versus standard investigation in patients with suspected chronic coronary syndrome referred from primary health care

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月21日

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  • Staffan Nilsson,
  • Fade Gabro,
  • Erik Stertman,
  • Lars Bernfort,
  • Mats Fredrikson,
  • Pontus Henriksson,
  • Peter Johansson,
  • Lisa Kastbom,
  • Anita Kärner Köhler,
  • Johan Lööf,
  • Ghassan Mourad,
  • Eva Olsson,
  • Carlos Valladares,
  • Carl Johan Östgren,
  • Sofia Sederholm Lawesson,
  • Jan Engvall,
  • Fredrik Iredahl

摘要

Background

This trial aims to assess the effectiveness of a novel diagnostic package in the investigation of symptomatic chronic coronary artery disease (CAD), with a focus on reducing the time to diagnosis and improving risk assessment, compared to the current standard investigation approach. The package investigation is comprised of combined single photon emission computed tomography (SPECT), echocardiography, coronary artery calcification (CAC) scoring, not previously evaluated in Sweden for individual cardiovascular prevention, and CadScore, an acoustic risk score. The standard investigation is comprised of exercise bicycle stress testing and echocardiography.

Methods

The trial involves patients with a pre-test probability > 15% for significant CAD referred from primary healthcare centers (PHCs) in Region Östergötland (population 471,241 in March 2023) in south-east Sweden. All the 47 PHCs of the region will be invited to participate and will, after approval, be cluster randomized into two groups: package investigation versus standard investigation. The primary outcome is a composite measure comprised of waiting time to invasive coronary angiography or communication of non-invasive myocardial ischemia investigation results. Secondary outcomes include major adverse cardiovascular events (MACE), cost per patient, signs of reversible ischemia on any test, radiation exposure, and adherence to prescribed cardioprotective drugs.

Discussion

This trial addresses the urgent problem of chest pain and dyspnea assessment in primary care and aims to speed up diagnosis, reduce the need for specialist consultations, and potentially improve patient outcomes, with referral to SPECT directly from PHC in comparison with the widely used exercise test. The novel approach includes CAC scoring. Additionally, the utility of acoustic CadScore in reclassifying the risk of CAD is explored.

Trial registration.

The trial was registered on March 11, 2023, at ClinicalTrials.gov with the identifier: NCT05782582.