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Coronary Artery Disease ProgressionNASCENTNCT06040073

Natural History of Coronary Atherosclerosis

An observational study of Coronary Artery Disease Progression and Radial Wall Strain, run by China National Center for Cardiovascular Diseases at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
125 participants
Where
1 siteChina
Study dates
7 Jul 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult study participants with acute myocardial infarction complicated by multi-vessel coronary artery diseases within 45 days.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Song, MD contact

01088322564

drsong@vip.163.com

China1 site, 1 recruiting

  • Lei Song

    Beijing, 100037

    Lei Song, MD, 01088322564, drsong@vip.163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion progression assessed by QCA

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

    Measured: 1 year

Secondary outcomes (13)

  1. Incidence of major adverse cardiac events (MACE)

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

    Measured: 1 year, 2 years, 3 years

  2. Incidence of all-cause death

    Including cardiac or non-cardiac death

    Measured: 1 year, 2 years, 3 years

  3. Incidence of new myocardial infarction

    Measured: 1 year, 2 years, 3 years

  4. Incidence of unplanned revascularization

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

    Measured: 1 year, 2 years, 3 years

  5. Incidence of stent thrombosis

    Including probable and definite stent thrombosis

    Measured: 1 year, 2 years, 3 years

  6. μQFR

    Angiography-derived FFR

    Measured: 1 year

  7. RWSmax, %

    Angiography-derived radial wall strain

    Measured: 1 year

  8. Diameter stenosis by QCA, %

    Measured by QCA

    Measured: 1 year

  9. Minimal fibrous cap thickness (FCTmin), mm

    Measured by OCT

    Measured: 1 year

  10. Lipid arc, °

    Measured by OCT

    Measured: 1 year

  11. Plaque burden, %

    Measured by OCT

    Measured: 1 year

  12. Index of plaque attenuation (IPA)

    Measured by OCT

    Measured: 1 year

  13. Virtual flow ratio (VFR)

    Measured by OCT

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start7 Jul 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06040073
Sponsor's protocol ID
2023-GSP-GG-3
Acronym
NASCENT
Status last verified
Nov 2024
First submitted
3 Sep 2023
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang Y, Sun Z, Yu B, Liu W, Gao H, Li J, Jin Z, Yu H, Zheng B, Guan C, Zhang H, Zhang Y, Gao L, Cui C, Song Y, Xu J, Dou K, Yang W, Qian J, Wu Y, Song L. Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study. BMJ Open. 2025 Oct 23;15(10):e105796. doi: 10.1136/bmjopen-2025-105796.

    PubMed 41130689

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease Progression and Radial Wall Strain, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Song, MD (01088322564, drsong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion progression assessed by QCA (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06040073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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