Menu
Recruiting NCT06040073

Natural History of Coronary Atherosclerosis

— Observational Coronary Artery Disease Progression Radial Wall Strain Atherosclerotic Lesion Optical Coherence Tomography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease Progression, Radial Wall Strain, Atherosclerotic Lesion, Optical Coherence Tomography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Primary outcome measures

  • Lesion progression assessed by QCA [Time frame: 1 year]
Secondary outcome measures (12)
  • Incidence of major adverse cardiac events (MACE) [Time frame: 1 year, 2 years, 3 years]
  • Incidence of all-cause death [Time frame: 1 year, 2 years, 3 years]
  • Incidence of new myocardial infarction [Time frame: 1 year, 2 years, 3 years]
  • Incidence of unplanned revascularization [Time frame: 1 year, 2 years, 3 years]
  • Incidence of stent thrombosis [Time frame: 1 year, 2 years, 3 years]
  • μQFR [Time frame: 1 year]
  • RWSmax, % [Time frame: 1 year]
  • Diameter stenosis by QCA, % [Time frame: 1 year]
  • Minimal fibrous cap thickness (FCTmin), mm [Time frame: 1 year]
  • Lipid arc, ° [Time frame: 1 year]
  • Plaque burden, % [Time frame: 1 year]
  • Index of plaque attenuation (IPA) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Lei Song — Beijing

Publications

  • 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

Identifiers

NCT: NCT06040073 · 2023-GSP-GG-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗