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Natural History of Coronary Atherosclerosis (NASCENT)

N

National Center for Cardiovascular Diseases

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT06040073
2023-GSP-GG-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • General Inclusion Criteria:

    1. Age ≥18 years
    2. Acute myocardial infarction ≤ 45 days
    3. Planned coronary angiography examination or potential interventional treatment
  • Angiographic Inclusion Criteria:

    1. 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:

    1. Cardiogenic shock
    2. Pregnant or woman of child-bearing potential
    3. Life expectancy less than 1 year for non-cardiac causes
    4. Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
    5. Prior CABG or planned CABG
  • Angiographic exclusion Criteria:

    1. 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
    2. An interrogated lesion require surgical bypass grafting
    3. Unable to judge culprit lesion or infarct-related artery according to current evidence

Trial contacts and locations

1

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Central trial contact

Lei Song, MD

Data sourced from clinicaltrials.gov

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