NASCENT: Natural History of Coronary Atherosclerosis

• Sponsor: China National Center for Cardiovascular Diseases (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06040073
• Collaborator: (none)
• Enrollment: 125
• Anticipated Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Progression; Radial Wall Strain; Atherosclerotic Lesion; Optical Coherence Tomography

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 Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2026

Outcome Measures

Primary Outcome Measures

1. Lesion progression assessed by QCA [1 year]

   Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation

Secondary Outcome Measures

1. 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

2. Incidence of all-cause death [1 year, 2 years, 3 years]

   Including cardiac or non-cardiac death

3. Incidence of new myocardial infarction [1 year, 2 years, 3 years]

4. Incidence of unplanned revascularization [1 year, 2 years, 3 years]

   Including infarction-related/non-infarction-related vessel revascularization

5. Incidence of stent thrombosis [1 year, 2 years, 3 years]

   Including probable and definite stent thrombosis

6. μQFR [1 year]

   Angiography-derived FFR

7. RWSmax, % [1 year]

   Angiography-derived radial wall strain

8. Diameter stenosis by QCA, % [1 year]

   Measured by QCA

9. Minimal fibrous cap thickness (FCTmin), mm [1 year]

   Measured by OCT

10. Lipid arc, ° [1 year]

    Measured by OCT

11. Plaque burden, % [1 year]

    Measured by OCT

12. Index of plaque attenuation (IPA) [1 year]

    Measured by OCT

13. Virtual flow ratio (VFR) [1 year]

    Measured by OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• China National Center for Cardiovascular Diseases

Investigators

• Principal Investigator: Lei Song, MD, Fuwai Hospital, CAMS & PUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Song, MD, Director of the Coronary Heart Disease Ward, First Section, China National Center for Cardiovascular Diseases
• ClinicalTrials.gov Identifier: NCT06040073
• Other Study ID Numbers: 2023-GSP-GG-3
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Disease Progression

Study Results

No Results Posted as of Sep 15, 2023