Natural History of Coronary Atherosclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)

Conditions
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Radial Wall Strain, Coronary Artery Disease Progression, Atherosclerotic Lesion, Optical Coherence Tomography

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion progression assessed by QCA | Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiac events (MACE) | Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization | 1 year, 2 years, 3 years | 
| Incidence of all-cause death | Including cardiac or non-cardiac death | 1 year, 2 years, 3 years | 
| Incidence of new myocardial infarction |  | 1 year, 2 years, 3 years | 
| Incidence of unplanned revascularization | Including infarction-related/non-infarction-related vessel revascularization | 1 year, 2 years, 3 years | 
| Incidence of stent thrombosis | Including probable and definite stent thrombosis | 1 year, 2 years, 3 years | 
| μQFR | Angiography-derived FFR | 1 year | 
| RWSmax, % | Angiography-derived radial wall strain | 1 year | 
| Diameter stenosis by QCA, % | Measured by QCA | 1 year | 
| Minimal fibrous cap thickness (FCTmin), mm | Measured by OCT | 1 year | 
| Lipid arc, ° | Measured by OCT | 1 year | 
| Plaque burden, % | Measured by OCT | 1 year | 
| Index of plaque attenuation (IPA) | Measured by OCT | 1 year | 
| Virtual flow ratio (VFR) | Measured by OCT | 1 year |