Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study.

IF 2.3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Yao Jiang, Zhongwei Sun, Bo Yu, Wei Liu, Hai Gao, Jianping Li, Zening Jin, Huai Yu, Bo Zheng, Changdong Guan, Han Zhang, Yin Zhang, Lijian Gao, Cheng Cui, Ying Song, Jingjing Xu, Kefei Dou, Weixian Yang, Jie Qian, Yongjian Wu, Lei Song
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引用次数: 0

Abstract

Introduction: Patients with acute myocardial infarction (AMI) and multivessel disease are at elevated risk of recurrent events. Radial wall strain (RWS), a novel indicator derived from angiography, has emerged as a potentially useful adjunct to optical coherence tomography (OCT) for assessing plaque vulnerability. The NASCENT trial is a prospective, multicentre cohort study designed to assess the natural history of coronary plaque in this high-risk AMI population and investigate the predictive value of angiography-based RWS for lesion progression, compared with OCT-assessed vulnerable plaque.

Methods and analysis: Following successful culprit lesion revascularisation for AMI patients with multivessel disease, we assessed eligible non-culprit lesions (30%-80% diameter stenosis) in non-flow-limiting, non-infarct-related arteries (Murray law-based quantitative flow ratio >0.80) using OCT and offline RWS analysis. The primary endpoint is lesion progression at 1 year, defined as a ≥20% increase in diameter stenosis percentage measured by quantitative coronary angiography. Between April 2024 and April 2025, 131 patients were enrolled. The 1-year angiographic and OCT follow-ups will be completed by May 2026. Clinical follow-ups are planned at 1 month, 6 months, 1 year and annually up to 3 years. As the first prospective trial comparing angiography-based RWS with OCT for predicting lesion progression in the AMI population, this study may provide crucial evidence for RWS as a valuable tool for risk stratification and clinical decision-making.

Ethics and dissemination: The protocol has been approved by the Institutional Review Board and Ethics Committee (Fuwai Hospital Approval No. 2023-2039) and will be conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants. The study results will undergo peer-reviewed publication.

Trial registration number: NCT06040073.

基于多模态成像和生理融合技术的冠状动脉粥样硬化的自然历史:研究方案和新生研究的基本原理。
急性心肌梗死(AMI)和多血管疾病患者复发的风险较高。桡骨壁应变(RWS)是一种源自血管造影的新指标,已成为光学相干断层扫描(OCT)评估斑块易损性的潜在有用辅助手段。新生试验是一项前瞻性、多中心队列研究,旨在评估高危AMI人群冠状动脉斑块的自然历史,并研究与oct评估的易损斑块相比,基于血管造影的RWS对病变进展的预测价值。方法和分析:在AMI合并多血管疾病患者的罪魁祸首病变血运重建成功后,我们使用OCT和离线RWS分析评估了非血流受限、非梗死相关动脉(Murray定律定量血流比>0.80)中符合条件的非罪魁祸首病变(30%-80%直径狭窄)。主要终点是1年的病变进展,定义为定量冠状动脉造影测量的直径狭窄百分比增加≥20%。在2024年4月至2025年4月期间,131名患者入组。为期一年的血管造影和OCT随访将于2026年5月完成。临床随访计划为1个月、6个月、1年和每年一次,最长可达3年。作为首个比较基于血管造影的RWS与OCT预测AMI人群病变进展的前瞻性试验,本研究可能为RWS作为风险分层和临床决策的有价值工具提供重要证据。伦理和传播:该方案已获得机构审查委员会和伦理委员会的批准(阜外医院批准号2023-2039),并将按照赫尔辛基宣言进行。获得了所有参与者的知情同意。研究结果将经过同行评议发表。试验注册号:NCT06040073。
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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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