Exploring coronary artery disease progression using radial wall strain

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

This study is testing if a new way to measure heart artery strain can help predict how quickly heart disease gets worse in people who recently had a heart attack.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing)
• Trial ID: NCT06040073 on ClinicalTrials.gov

What this trial studies

This observational study investigates the predictive value of radial wall strain (RWS) derived from angiograms for the progression of coronary artery lesions compared to lesion vulnerability assessed by optical coherence tomography (OCT). It involves a multicenter, prospective cohort of individuals who have experienced an acute myocardial infarction within the last 45 days. The study aims to determine if RWS can effectively predict disease progression at one year, using a specific threshold for identifying vulnerable lesions. The findings may help optimize strategies for identifying high-risk plaques in patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had an acute myocardial infarction within the last 45 days and are scheduled for coronary angiography.

Not a fit: Patients with cardiogenic shock, those who are pregnant, or individuals with a life expectancy of less than one year for non-cardiac causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict coronary artery disease progression, leading to better patient management and outcomes.

How similar studies have performed: While the approach of using radial wall strain is relatively novel, similar studies utilizing optical coherence tomography have shown promise in assessing lesion vulnerability.

Eligibility criteria

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

Where this trial is running

Beijing

• Lei Song — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lei Song, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Lei Song, MD

Conditions Coronary Artery Disease Progression; Radial Wall Strain; Atherosclerotic Lesion; Optical Coherence Tomography