vicad风险研究的基本原理和设计：冠状动脉疾病的可视化以改变危险因素。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-04-03 DOI:10.1016/j.ahj.2025.04.002

Archana Kulasingam MD , Sussie Laustsen MSN, PhD , Martin Busk MD, PhD , Niels-Peter Rønnow Sand MD, PhD , Simon Winther MD, PhD, DMSci , Kristian Kragholm MD, PhD , Osama Hammid MD , Kamilla Bech Pedersen , Peter Vedsted MD, PhD , Helle Kanstrup MD, PhD , Martin Bødtker Mortensen MD, PhD , Erik Lerkevang Grove MD, PhD , Jesper Møller Jensen MD, PhD , Bjarne Linde Nørgaard MD, PhD, DMSci

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引用次数: 0

摘要

背景：随着冠状动脉计算机断层扫描（CTA）应用的日益广泛，非阻塞性冠状动脉粥样硬化性疾病（NOCAD）患者的发病率也在不断上升。非阻塞性冠状动脉疾病的存在与不良临床结果的风险增加有关。因此，以他汀类药物为指导的降脂治疗等预防策略非常重要。本研究旨在评估向新诊断为 NOCAD 的患者展示个人 CTA 图像是否有助于降低低密度脂蛋白胆固醇（主要终点）、提高他汀类药物的依从性、影响对他汀类药物相关副作用的感知以及改变冠状动脉粥样硬化表型：VICAD-RISK研究是一项丹麦多中心随机试验，研究对象包括一线冠状动脉CTA新诊断为NOCAD的慢性冠状动脉综合征疑似患者。共有 273 名患者将按 1:1:1 的比例被随机分为：（1）常规护理；代表当前临床实践的全科医生随访；（2）低强度干预；专业护士咨询；或（3）高强度干预；类似于第 2 组并展示个人 CTA 图像。包括干预组在内的所有参与者都将由其全科医生决定是否接受随访。所有参与者将在 12 个月后再次接受包括生化测量和冠状动脉 CTA 检查在内的后续研究：VICAD-RISK研究评估了新诊断为NOCAD患者的个人CTA图像可视化是否能改善低密度脂蛋白胆固醇的降低：试验注册：ClinicalTrials.gov, NCT06413641, www.Clinicaltrials: gov.

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Rationale and design of VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors

Background

With the increasing use of coronary computed tomography angiography (CTA), the prevalence of patients with nonobstructive atherosclerotic coronary artery disease (NOCAD) is growing. Presence of NOCAD is associated with an increased risk of an unfavorable clinical outcome. Therefore, guideline-directed preventive strategies such as lipid-lowering therapy with statins are important. This study aims to assess whether visualization of personal CTA images to patients with a new diagnosis of NOCAD facilitates reduction of low-density lipoprotein (LDL) cholesterol (primary endpoint), improves statin adherence, influences the perception of statin-associated side effects, and modifies the coronary atherosclerotic phenotype.

Methods

The VICAD-RISK study is a Danish multicenter randomized trial including statin naïve patients suspected of chronic coronary syndrome with a new diagnosis of NOCAD determined by first-line coronary CTA. A total of 273 patients will be randomized 1:1:1 into; (1) usual care; representing current clinical practice of general practitioner follow-up; (2) low-intensity intervention; specialized nurse consultation, or (3) high-intensity intervention; similar to group 2 and presentation of the personal CTA-images. All participants, including the intervention groups, will be followed at the discretion of their general practitioner. Research follow-up including biochemistry measurements, and coronary CTA investigation will be repeated for all participants after 12 months.

Conclusion

The VICAD-RISK study evaluates whether personal CTA image visualization in patients with a new diagnosis of NOCAD improves reduction of LDL cholesterol.

Trial registration

ClinicalTrials.gov, NCT06413641, www.clinicaltrials.gov.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.