Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study.
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.
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.
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.
NCT06040073.
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.
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.
NCT06040073.
Authors
Jiang Jiang, Sun Sun, Yu Yu, Liu Liu, Gao Gao, Li Li, Jin Jin, Yu Yu, Zheng Zheng, Guan Guan, Zhang Zhang, Zhang Zhang, Gao Gao, Cui Cui, Song Song, Xu Xu, Dou Dou, Yang Yang, Qian Qian, Wu Wu, Song Song
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