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Natural History of Coronary Atherosclerosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06040073
Acronym
NASCENT
Enrollment
125
Registered
2023-09-15
Start date
2024-07-07
Completion date
2026-12-31
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Lesion progression assessed by QCA1 yearDefined as an increase of ≥20% in diameter stenosis based on QCA evaluation

Secondary

MeasureTime frameDescription
Incidence of all-cause death1 year, 2 years, 3 yearsIncluding cardiac or non-cardiac death
Incidence of new myocardial infarction1 year, 2 years, 3 years
Incidence of unplanned revascularization1 year, 2 years, 3 yearsIncluding infarction-related/non-infarction-related vessel revascularization
Incidence of stent thrombosis1 year, 2 years, 3 yearsIncluding probable and definite stent thrombosis
μQFR1 yearAngiography-derived FFR
RWSmax, %1 yearAngiography-derived radial wall strain
Incidence of major adverse cardiac events (MACE)1 year, 2 years, 3 yearsDefined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization
Minimal fibrous cap thickness (FCTmin), mm1 yearMeasured by OCT
Lipid arc, °1 yearMeasured by OCT
Plaque burden, %1 yearMeasured by OCT
Index of plaque attenuation (IPA)1 yearMeasured by OCT
Virtual flow ratio (VFR)1 yearMeasured by OCT
Diameter stenosis by QCA, %1 yearMeasured by QCA

Countries

China

Contacts

Primary ContactLei Song, MD
drsong@vip.163.com01088322564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026