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

IF 3.4 3区医学 Q1 HEALTH POLICY & SERVICES

Health Policy and Technology Pub Date : 2024-06-12 DOI:10.1016/j.hlpt.2024.100881

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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引用次数: 0

Abstract

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.

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评估动态心肌血流激发作为冠心病患者具有成本效益的护理模式（NUCLEuS）：随机对照试验 - 原理与设计

背景使用动态 SPECT MPI 定量心肌血流（MBF）和冠状动脉血流储备的最新进展表明，其血流动力学相关性与有创血管造影和 PET 相当。然而，将其应用于常规临床实践对资源提出了相应的要求。方法NUCLEuS是一项正在进行的前瞻性开放标签随机临床试验，将在2022年3月至2025年3月期间招募300名临床转诊的无已知冠状动脉疾病（CAD）的糖尿病患者进行SPECT MPI检查。目的是确定动态 MBF 与传统 SPECT 相比，对疑似 CAD 的糖尿病患者的预后价值增量和检测后资源利用率。主要终点是诊断失败，定义为 90 天内不必要的冠状动脉造影（≥1 支冠状动脉没有≥50% 的狭窄）或额外的解剖检查（如冠状动脉计算机断层扫描血管造影）。次要终点是转诊进行血管造影术或血管重建术、抗心绞痛药物升级以及 12 个月的生活质量评分。长期终点为 36 个月内的主要不良心血管事件（心脏病死亡率、心肌梗死、不稳定型心绞痛、血管再通）。结论NUCLEuS 将是一项以成像为导向的临床试验，它将比较动态 MBF 与传统 SPECT MPI 在糖尿病患者 CAD 常规临床管理中的结果和资源利用率的差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Policy and Technology Medicine-Health Policy

CiteScore

9.20

自引率

3.30%

发文量

审稿时长

88 days

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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