Actively Recruiting
Natural History of Coronary Atherosclerosis Based on Multimodal Imaging and Physiological Fusion Techniques (NASCENT)
Led by China National Center for Cardiovascular Diseases · Updated on 2024-11-06
125
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the predictive value of radial wall strain (RWS), a measure derived from coronary angiograms, for the progression of coronary artery lesions compared to lesion vulnerability assessed by optical coherence tomography (OCT). The study focuses on patients who have had an acute myocardial infarction within the past 45 days, aiming to determine if RWS can identify vulnerable plaques and predict disease progression over one year. This prospective, multicenter observational study seeks to enhance methods for detecting high-risk coronary lesions. The study computes the maximum radial wall strain (RWSmax) as the maximum deformation of the coronary artery lumen diameter during the cardiac cycle, expressed as a percentage. Participants undergo coronary angiography and potentially interventional treatment to evaluate lesions with 30%-80% diameter stenosis that do not restrict blood flow. The study compares the ability of RWSmax (using a threshold of 13%) and OCT to predict lesion progression defined as a 20% or greater increase in artery narrowing at one year. Participants will be monitored over the course of one year, with assessments including quantitative coronary angiography (QCA) to measure lesion progression. Secondary outcomes include major adverse cardiac events, all-cause death, new myocardial infarction, unplanned revascularization, stent thrombosis, and various imaging and physiological parameters measured at 1, 2, and 3 years. The study involves repeated imaging and physiological evaluations to understand lesion behavior and disease progression in coronary artery disease patients.
CONDITIONS
Brief Title
Natural History of Coronary Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute myocardial infarction occurring within 45 days
- Planned coronary angiography examination or potential interventional treatment
- Presence of at least one non-flow-restricting lesion with 30% to 80% diameter stenosis in a non-infarct related artery
- Reference vessel diameter of 2.5 mm or greater by visual assessment
You will not qualify if you...
- Cardiogenic shock
- Pregnant or woman of child-bearing potential
- Life expectancy less than 1 year due to non-cardiac causes
- Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
- Prior coronary artery bypass grafting (CABG) or planned CABG
- Poor angiographic image quality preventing vessel contour detection
- Branch ostium not clearly visible or severe vessel overlap/tortuosity unsuitable for measurements
- Lesion requiring surgical bypass grafting
- Unable to identify culprit lesion or infarct-related artery based on current evidence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 45 days after acute myocardial infarction
Participants undergo coronary angiography and multimodal imaging to assess coronary lesions and identify vulnerable plaques.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored over time to assess lesion progression and cardiac events through imaging and clinical follow-up.
Follow-up visits at 1 year, 2 years, and 3 years
Trial Site Locations
Total: 1 location
1
Lei Song
Beijing, China, 100037
Actively Recruiting
Research Team
L
Lei Song, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0