Natural History of Coronary Atherosclerosis (NASCENT)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Lei Song, MD; Phone Number: 01088322564; Email: drsong@vip.163.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Lei Song
    • Contact: Lei Song, MD; Phone Number: 01088322564; Email: drsong@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult study participants with acute myocardial infarction complicated by multi-vessel coronary artery diseases within 45 days.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion progression assessed by QCA	Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Lei Song, MD, Fuwai Hospital, CAMS & PUMC

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Disease Progression; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 2023-GSP-GG-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No