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NCT Number: NCT06040073

Natural History of Coronary Atherosclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General Inclusion Criteria:
  • Age ≥18 years
  • Acute myocardial infarction ≤ 45 days
  • Planned coronary angiography examination or potential interventional treatment
  • Angiographic Inclusion Criteria:
  • 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:
  • Cardiogenic shock
  • Pregnant or woman of child-bearing potential
  • Life expectancy less than 1 year for non-cardiac causes
  • Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
  • Prior CABG or planned CABG
  • Angiographic exclusion Criteria:
  • 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
  • An interrogated lesion require surgical bypass grafting
  • Unable to judge culprit lesion or infarct-related artery according to current evidence

Treatment and study plan

Primary outcomes

  1. Lesion progression assessed by QCA

    Time frame: 1 year

    Defined as an increase of ≥20% in diameter stenosis based on QCA evaluation

Secondary outcomes

  1. Incidence of major adverse cardiac events (MACE)

    Time frame: 1 year, 2 years, 3 years

    Defined as a composite endpoint of all-cause death, new myocardial infarction, and unplanned revascularization

  2. Incidence of all-cause death

    Time frame: 1 year, 2 years, 3 years

    Including cardiac or non-cardiac death

  3. Incidence of new myocardial infarction

    Time frame: 1 year, 2 years, 3 years

  4. Incidence of unplanned revascularization

    Time frame: 1 year, 2 years, 3 years

    Including infarction-related/non-infarction-related vessel revascularization

  5. Incidence of stent thrombosis

    Time frame: 1 year, 2 years, 3 years

    Including probable and definite stent thrombosis

  6. μQFR

    Time frame: 1 year

    Angiography-derived FFR

  7. RWSmax, %

    Time frame: 1 year

    Angiography-derived radial wall strain

  8. Diameter stenosis by QCA, %

    Time frame: 1 year

    Measured by QCA

  9. Minimal fibrous cap thickness (FCTmin), mm

    Time frame: 1 year

    Measured by OCT

  10. Lipid arc, °

    Time frame: 1 year

    Measured by OCT

  11. Plaque burden, %

    Time frame: 1 year

    Measured by OCT

  12. Index of plaque attenuation (IPA)

    Time frame: 1 year

    Measured by OCT

  13. Virtual flow ratio (VFR)

    Time frame: 1 year

    Measured by OCT

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Song, MD

CONTACT

[email protected]

01088322564

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: NASCENT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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