Actively Recruiting

Age: 18Years +
All Genders
ID06040073

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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

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Published Research Related To This Trial

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