Clinical trial NCT06040073: Natural History of Coronary Atherosclerosis
Official title: Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease Progression
Radial Wall Strain
Atherosclerotic Lesion
Optical Coherence Tomography
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-09-15
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult study participants with acute myocardial infarction complicated by multi-vessel coronary artery diseases within 45 days.

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.

Eligibility criteria: 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 outcomes:
measure: Lesion progression assessed by QCA
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of major adverse cardiac events (MACE)
timeFrame: 1 year, 2 years, 3 years
measure: Incidence of all-cause death
timeFrame: 1 year, 2 years, 3 years
measure: Incidence of new myocardial infarction
timeFrame: 1 year, 2 years, 3 years
measure: Incidence of unplanned revascularization
timeFrame: 1 year, 2 years, 3 years
measure: Incidence of stent thrombosis
timeFrame: 1 year, 2 years, 3 years
measure: μQFR
timeFrame: 1 year
measure: RWSmax, %
timeFrame: 1 year
measure: Diameter stenosis by QCA, %
timeFrame: 1 year
measure: Minimal fibrous cap thickness (FCTmin), mm
timeFrame: 1 year
measure: Lipid arc, °
timeFrame: 1 year
measure: Plaque burden, %
timeFrame: 1 year
measure: Index of plaque attenuation (IPA)
timeFrame: 1 year
measure: Virtual flow ratio (VFR)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Song
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lei Song, MD
role: PRINCIPAL_INVESTIGATOR
References: