Jie Jun Wong , Louis LY Teo , Fei Gao , Liang Zhong , Weimin Huang , Nicholas Graves , Ru-San Tan , Terrance SJ Chua , Felix JY Keng , Angela S. Koh
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Diabetes mellitus is a rising pandemic associated with accelerated atherosclerosis, yet there is potential for under-detection of significant ischemia.</p></div><div><h3>Objectives</h3><p>We postulate that quantifying myocardial blood flow (MBF) by dynamic SPECT reduces post-test resource utilization and improve economic efficiency over conventional SPECT.</p></div><div><h3>Methods</h3><p>NUCLEuS is an ongoing prospective open-label randomized clinical trial that will enroll 300 diabetic patients without known coronary artery disease (CAD) referred clinically for SPECT MPI from March 2022 to March 2025. The aim is to determine the incremental prognostic value and post-test resource utilization of dynamic MBF over conventional SPECT in diabetic patients with suspected CAD. The primary endpoint is diagnostic failure, defined as unnecessary coronary angiography (absence of ≥50% stenosis in ≥1 coronary artery) or additional anatomical testing (e.g., coronary computed tomography angiography) within 90 days. Secondary endpoints are referrals for angiography or revascularization, escalation of anti-anginal medications, and quality-of-life scores at 12 months. Long-term endpoints are major adverse cardiovascular events (cardiac mortality, myocardial infarction, unstable angina, revascularization) within 36 months. The incremental cost-effectiveness ratio will be estimated based on cost and clinical effectiveness.</p></div><div><h3>Conclusions</h3><p>NUCLEuS will be an imaging-directed clinical trial that will compare differences in outcomes and resource utilization of dynamic MBF over conventional SPECT MPI in the routine clinical management of CAD in diabetes mellitus.</p></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 3","pages":"Article 100881"},"PeriodicalIF":3.4000,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluating dyNamic myocardial blood flow qUantitation as a Cost-effective care modeL for diabEtic patients with coronary artery diSease (NUCLEuS): A randomized controlled trial – Rationale and Design\",\"authors\":\"Jie Jun Wong , Louis LY Teo , Fei Gao , Liang Zhong , Weimin Huang , Nicholas Graves , Ru-San Tan , Terrance SJ Chua , Felix JY Keng , Angela S. Koh\",\"doi\":\"10.1016/j.hlpt.2024.100881\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Recent advancements in quantifying myocardial blood flow (MBF) and coronary flow reserve using dynamic SPECT MPI have demonstrated comparable hemodynamic correlations with invasive angiography and PET. Implementation into routine practice, however, imposes attendant demands on resources. Diabetes mellitus is a rising pandemic associated with accelerated atherosclerosis, yet there is potential for under-detection of significant ischemia.</p></div><div><h3>Objectives</h3><p>We postulate that quantifying myocardial blood flow (MBF) by dynamic SPECT reduces post-test resource utilization and improve economic efficiency over conventional SPECT.</p></div><div><h3>Methods</h3><p>NUCLEuS is an ongoing prospective open-label randomized clinical trial that will enroll 300 diabetic patients without known coronary artery disease (CAD) referred clinically for SPECT MPI from March 2022 to March 2025. The aim is to determine the incremental prognostic value and post-test resource utilization of dynamic MBF over conventional SPECT in diabetic patients with suspected CAD. The primary endpoint is diagnostic failure, defined as unnecessary coronary angiography (absence of ≥50% stenosis in ≥1 coronary artery) or additional anatomical testing (e.g., coronary computed tomography angiography) within 90 days. Secondary endpoints are referrals for angiography or revascularization, escalation of anti-anginal medications, and quality-of-life scores at 12 months. Long-term endpoints are major adverse cardiovascular events (cardiac mortality, myocardial infarction, unstable angina, revascularization) within 36 months. The incremental cost-effectiveness ratio will be estimated based on cost and clinical effectiveness.</p></div><div><h3>Conclusions</h3><p>NUCLEuS will be an imaging-directed clinical trial that will compare differences in outcomes and resource utilization of dynamic MBF over conventional SPECT MPI in the routine clinical management of CAD in diabetes mellitus.</p></div>\",\"PeriodicalId\":48672,\"journal\":{\"name\":\"Health Policy and Technology\",\"volume\":\"13 3\",\"pages\":\"Article 100881\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-06-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Health Policy and Technology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2211883724000443\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH POLICY & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Policy and Technology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2211883724000443","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
Evaluating dyNamic myocardial blood flow qUantitation as a Cost-effective care modeL for diabEtic patients with coronary artery diSease (NUCLEuS): A randomized controlled trial – Rationale and Design
Background
Recent advancements in quantifying myocardial blood flow (MBF) and coronary flow reserve using dynamic SPECT MPI have demonstrated comparable hemodynamic correlations with invasive angiography and PET. Implementation into routine practice, however, imposes attendant demands on resources. Diabetes mellitus is a rising pandemic associated with accelerated atherosclerosis, yet there is potential for under-detection of significant ischemia.
Objectives
We postulate that quantifying myocardial blood flow (MBF) by dynamic SPECT reduces post-test resource utilization and improve economic efficiency over conventional SPECT.
Methods
NUCLEuS is an ongoing prospective open-label randomized clinical trial that will enroll 300 diabetic patients without known coronary artery disease (CAD) referred clinically for SPECT MPI from March 2022 to March 2025. The aim is to determine the incremental prognostic value and post-test resource utilization of dynamic MBF over conventional SPECT in diabetic patients with suspected CAD. The primary endpoint is diagnostic failure, defined as unnecessary coronary angiography (absence of ≥50% stenosis in ≥1 coronary artery) or additional anatomical testing (e.g., coronary computed tomography angiography) within 90 days. Secondary endpoints are referrals for angiography or revascularization, escalation of anti-anginal medications, and quality-of-life scores at 12 months. Long-term endpoints are major adverse cardiovascular events (cardiac mortality, myocardial infarction, unstable angina, revascularization) within 36 months. The incremental cost-effectiveness ratio will be estimated based on cost and clinical effectiveness.
Conclusions
NUCLEuS will be an imaging-directed clinical trial that will compare differences in outcomes and resource utilization of dynamic MBF over conventional SPECT MPI in the routine clinical management of CAD in diabetes mellitus.
期刊介绍：
Health Policy and Technology (HPT), is the official journal of the Fellowship of Postgraduate Medicine (FPM), a cross-disciplinary journal, which focuses on past, present and future health policy and the role of technology in clinical and non-clinical national and international health environments.
HPT provides a further excellent way for the FPM to continue to make important national and international contributions to development of policy and practice within medicine and related disciplines. The aim of HPT is to publish relevant, timely and accessible articles and commentaries to support policy-makers, health professionals, health technology providers, patient groups and academia interested in health policy and technology.
Topics covered by HPT will include:
- Health technology, including drug discovery, diagnostics, medicines, devices, therapeutic delivery and eHealth systems
- Cross-national comparisons on health policy using evidence-based approaches
- National studies on health policy to determine the outcomes of technology-driven initiatives
- Cross-border eHealth including health tourism
- The digital divide in mobility, access and affordability of healthcare
- Health technology assessment (HTA) methods and tools for evaluating the effectiveness of clinical and non-clinical health technologies
- Health and eHealth indicators and benchmarks (measure/metrics) for understanding the adoption and diffusion of health technologies
- Health and eHealth models and frameworks to support policy-makers and other stakeholders in decision-making
- Stakeholder engagement with health technologies (clinical and patient/citizen buy-in)
- Regulation and health economics
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