Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study.
Yao Jiang, Zhongwei Sun, Bo Yu...
https://pubmed.ncbi.nlm.nih.gov/41130689/Actively Recruiting
Led by China National Center for Cardiovascular Diseases · Updated on 2024-11-06
125
Participants Needed
1
Research Sites
78 weeks
Total Duration
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
Natural History of Coronary Atherosclerosis
L
Lei Song, MD
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China National Center for Cardiovascular Diseases
Lead Sponsor
You may qualify if you...
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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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Yao Jiang, Zhongwei Sun, Bo Yu...
https://pubmed.ncbi.nlm.nih.gov/41130689/China National Center for Cardiovascular Diseases
Lead Sponsor