一项基于多学科团队的方法指导外周动脉疾病患者心血管和肢体结局的二级风险预防的随机对照试验（TEAM-PAD）研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-12 DOI:10.1016/j.cct.2025.107844

Ritesh Chimoriya , Sophie James , Leonard Kritharides , Janani Thillainadesan , Samim Behdasht , Shaundeep Sen , Avinash Suryawanshi , Huw Davie , Amy Kitajima , Sarah Joy Aitken

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引用次数: 0

摘要

背景：外周动脉疾病(1)是一种与心血管发病率和死亡率相关的血管疾病。有效的二级预防策略对于改善PAD患者的心血管预后至关重要。team -PAD研究旨在确定集中虚拟多学科团队（MDT）护理模式是否有效地改善指南推荐的门诊PAD患者的继发性心血管风险降低。方法：TEAM-PAD是一项涉及PAD患者的多中心随机对照试验。参与者将被随机分为两组：干预组，他们将接受由集中MDT提供的心血管风险降低建议支持的护理；而对照组，他们将接受血管外科医生的常规护理。MDT将由以下临床医生组成：血管外科医生、心脏病专家、内分泌专家、肾病专家、老年病专家、药物健康医生和临床药剂师。主要结果是基线至9个月随访期间个体10年心血管风险综合测量的变化。次要结局包括可改变的心血管危险因素的控制和药物优化、心血管和肢体结局、PAD症状控制、生活质量结局和卫生服务使用结局。结论：本文详细介绍了TEAM-PAD试验方案，这将为基于mdt的方法降低PAD患者心血管风险的益处提供强有力的证据。TEAM-PAD有潜力为临床实践提供信息，证明协调的个性化护理建议是否可以改善这一高危人群的心血管风险，并潜在地减少心血管事件。试验注册：本研究已在澳大利亚新西兰临床试验注册中心注册（注册号：ACTRN12623000995673）。

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A randomised controlled trial of a multidisciplinary TEAM-based approach to guide secondary cardiovascular risk reduction for patients with Peripheral Artery Disease (TEAM-PAD) study protocol

Background

Peripheral arterial disease (1) is a vascular condition associated with significant cardiovascular morbidity and mortality. Effective secondary prevention strategies are essential to improve cardiovascular outcomes in patients with PAD. The TEAM-PAD study aims to determine if a centralised virtual multidisciplinary team (MDT) model of care is effective in improving guideline-recommended secondary cardiovascular risk reduction for outpatients with PAD.

Methods

TEAM-PAD is a multicentre, randomised controlled trial involving patients with PAD. Participants will be randomised into two groups: the intervention group, who will receive care supported by cardiovascular risk reduction recommendations from a centralised MDT; and the control group, who will receive usual care by their vascular surgeon. The MDT will consist of the following clinicians: vascular surgeon, cardiologist, endocrinologist, nephrologist, geriatrician, drug health physician and clinical pharmacist. The primary outcome is the change in a composite measure of an individual's 10-year cardiovascular risk between baseline to 9-months follow-up. Secondary outcomes include control of modifiable cardiovascular risk factors and medication optimisation, cardiovascular and limb outcomes, PAD symptom control, quality of life outcomes, and health-service use outcomes.

Conclusion

This article details the TEAM-PAD trial protocol, which will provide robust evidence on the benefits of an MDT-based approach to cardiovascular risk reduction in PAD patients. TEAM-PAD has the potential to inform clinical practice by demonstrating whether coordinated, personalised care recommendations can improve cardiovascular risk and potentially reduce cardiovascular events in this high-risk population.

Trial Registration: This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.