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Recruiting Observational

Natural History of Coronary Atherosclerosis

NCT06040073 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-07-07
Last updated
2024-11-06

Condition(s) studied

Coronary Artery Disease ProgressionRadial Wall StrainAtherosclerotic LesionOptical Coherence Tomography

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Lesion progression assessed by QCA — 1 year
    Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation

Trial sites (1)

FacilityCityRegionStatus
Lei Song Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06040073 on ClinicalTrials.gov ↗ ← All trials in China