Natural History of Coronary Atherosclerosis
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Disease Progression, Radial Wall Strain, Atherosclerotic Lesion, Optical Coherence Tomography. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)
Обзор
The present study sought to explore the predictive value of radial wall strain (RWS, derived solely from angiograms) for coronary artery lesion progression compared with lesion vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1 year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary angiography (QCA) evaluation.
Подробное описание
The recently developed angiography-derived maximum RWS (RWSmax) was computed as the maximum deformation of lumen diameter throughout the cardiac cycle, expressed as a percentage of the largest lumen diameter. This approach offers a quantitative assessment of the biomechanical attributes of coronary lesions. Consequently, it allows for the identification of lesion vulnerability, potentially compensating for the limitations of intravascular imaging in assessing lesion stability and optimizing strategies for identifying high-risk vulnerable plaques in patients.
In the present multicenter, prospective cohort of individuals with acute myocardial infarction, we assessed the predictive significance of identifying vulnerable lesions using an RWSmax threshold of ≥13%. The investigation aimed to determine the capacity of these identified lesions to predict the progression of the disease at 1 year. Furthermore, the study validated that predictive capacity of RWSmax was on par with, and not inferior to, lesion vulnerability assessed by OCT in tracking lesion progression.
Первичные конечные точки
- Lesion progression assessed by QCA [Срок оценки: 1 year]
Вторичные конечные точки (12)
- Incidence of major adverse cardiac events (MACE) [Срок оценки: 1 year, 2 years, 3 years]
- Incidence of all-cause death [Срок оценки: 1 year, 2 years, 3 years]
- Incidence of new myocardial infarction [Срок оценки: 1 year, 2 years, 3 years]
- Incidence of unplanned revascularization [Срок оценки: 1 year, 2 years, 3 years]
- Incidence of stent thrombosis [Срок оценки: 1 year, 2 years, 3 years]
- μQFR [Срок оценки: 1 year]
- RWSmax, % [Срок оценки: 1 year]
- Diameter stenosis by QCA, % [Срок оценки: 1 year]
- Minimal fibrous cap thickness (FCTmin), mm [Срок оценки: 1 year]
- Lipid arc, ° [Срок оценки: 1 year]
- Plaque burden, % [Срок оценки: 1 year]
- Index of plaque attenuation (IPA) [Срок оценки: 1 year]
Критерии участия
Критерии включения
- General Inclusion Criteria:
- Age ≥18 years
- Acute myocardial infarction ≤ 45 days
- Planned coronary angiography examination or potential interventional treatment
- Angiographic Inclusion Criteria:
- The presence of at least 1 non-flow-restricting lesion (visually estimated diameter stenosis: 30%-80%; QFR > 0.80) in any non-infarct related artery with RVD ≥2.5 mm by visual assessment
Критерии исключения
- General exclusion Criteria:
- Cardiogenic shock
- Pregnant or woman of child-bearing potential
- Life expectancy less than 1 year for non-cardiac causes
- Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
- Prior CABG or planned CABG
- Angiographic exclusion Criteria:
- Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to QFR or RWS measurement
- An interrogated lesion require surgical bypass grafting
- Unable to judge culprit lesion or infarct-related artery according to current evidence
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Lei Song — Пекин
Публикации
- Jiang Y, Sun Z, Yu B, Liu W, Gao H, Li J, Jin Z, Yu H, Zheng B, Guan C, Zhang H, Zhang Y, Gao L, Cui C, Song Y, Xu J, Dou K, Yang W, Qian J, Wu Y, Song L. Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study. BMJ Open. 2025 Oct 23;15(10):e105796. doi: 10.1136/bmjopen-2025-105796. PMID 41130689
Идентификаторы
NCT: NCT06040073 · 2023-GSP-GG-3