Natural History of Coronary Atherosclerosis

Optical Coherence Tomography Clinical Trial

— NASCENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06040073
• Other study ID #: 2023-GSP-GG-3
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Lei Song, MD
• Phone: 01088322564
• Email: drsong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Artery Disease Progression
• Disease Progression
• Myocardial Ischemia
• Optical Coherence Tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion progression assessed by QCA	Defined as an increase of =20% in diameter stenosis based on QCA evaluation	1 year
Secondary	Incidence of major adverse cardiac events (MACE)	Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization	1 year, 2 years, 3 years
Secondary	Incidence of all-cause death	Including cardiac or non-cardiac death	1 year, 2 years, 3 years
Secondary	Incidence of new myocardial infarction		1 year, 2 years, 3 years
Secondary	Incidence of unplanned revascularization	Including infarction-related/non-infarction-related vessel revascularization	1 year, 2 years, 3 years
Secondary	Incidence of stent thrombosis	Including probable and definite stent thrombosis	1 year, 2 years, 3 years
Secondary	µQFR	Angiography-derived FFR	1 year
Secondary	RWSmax, %	Angiography-derived radial wall strain	1 year
Secondary	Diameter stenosis by QCA, %	Measured by QCA	1 year
Secondary	Minimal fibrous cap thickness (FCTmin), mm	Measured by OCT	1 year
Secondary	Lipid arc, °	Measured by OCT	1 year
Secondary	Plaque burden, %	Measured by OCT	1 year
Secondary	Index of plaque attenuation (IPA)	Measured by OCT	1 year
Secondary	Virtual flow ratio (VFR)	Measured by OCT	1 year