Natural History of Coronary Atherosclerosis

Recruiting

• Conditions: Atherosclerotic Lesion; Optical Coherence Tomography; Coronary Artery Disease Progression; Radial Wall Strain

• Registration Number: NCT06040073
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

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.

Study Timeline

• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-15
• Study Start: 2024-07-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lei Song; 🇨🇳 Beijing, China