Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Lesion progression assessed by QCA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Lesion progression assessed by QCA
时间窗: 1 year
Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation
次要结局
- Index of plaque attenuation (IPA)(1 year)
- Virtual flow ratio (VFR)(1 year)
- Diameter stenosis by QCA, %(1 year)
- Lipid arc, °(1 year)
- Plaque burden, %(1 year)
- RWSmax, %(1 year)
- Minimal fibrous cap thickness (FCTmin), mm(1 year)
- Incidence of new myocardial infarction(1 year, 2 years, 3 years)
- Incidence of major adverse cardiac events (MACE)(1 year, 2 years, 3 years)
- Incidence of all-cause death(1 year, 2 years, 3 years)
- Incidence of stent thrombosis(1 year, 2 years, 3 years)
- μQFR(1 year)
- Incidence of unplanned revascularization(1 year, 2 years, 3 years)
研究者
Lei Song, MD
Director of the Coronary Heart Disease Ward, First Section
China National Center for Cardiovascular Diseases