Clinical trial Recruiting at 1 site Observational Ages 20 and up

Examining plaque characteristics in patients deferred from coronary intervention

Official title: CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Deferral Patients by Invasive Fractional Flow Reserve

Run by Fujita Health University · NCT06508697 · Data updated 2026-11-12

This study is trying to see if certain types of plaque in the arteries can help predict heart problems in patients who were not treated with a heart procedure.

Quick facts

Study typeObservational
Ages20 Years and up
SexAll
Enrollment400 (estimated)
SponsorFujita Health University
Academic / other
Locations1 site (Toyoake, Aichi-ken)
StatusRecruiting
StartedJanuary 30, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedJanuary 3, 2025
Trial IDNCT06508697 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men and women aged 20 years and older with chronic coronary syndromes who have undergone CTA within 90 days prior to invasive coronary angiography.

Probably not a fit

Patients with a history of coronary bypass grafting, left-main disease, or those with FFR in stented vessels may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between coronary computed tomography angiography (CTA) defined high-risk plaque characteristics and future cardiac events in patients who have been deferred from percutaneous coronary intervention (PCI) based on fractional flow reserve (FFR) measurements. The study aims to identify plaque features that may predict long-term cardiac outcomes in these patients. By analyzing data from patients with chronic coronary syndromes (CCS) who underwent CTA prior to invasive coronary angiography, the researchers hope to uncover factors that contribute to cardiac events despite initial deferral. This could lead to improved risk stratification and management strategies for patients with similar profiles.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict cardiac events in patients deferred from intervention, leading to better patient management and outcomes.

How similar studies have gone: While this approach is based on established methods, the specific focus on high-risk plaque characteristics in deferred patients is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* men and women aged ≥20 years,
* patients having chronic coronary syndromes (CCS,
* Coronary computed tomography angiography (CTA) was performed within 90 days before invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement.

Exclusion Criteria:

* patients with a history of coronary bypass grafting (CABG) because CABG changed local coronary flow dynamics,
* patients with left-main disease,
* patients with fractional flow reserve (FFR) in stented vessels due to inability to estimate plaque morphology in the stented lesion by coronary computed tomography angiography.

Where it's running

  • Fujita Health University
    Toyoake, Aichi-ken, Japan
    Recruiting

Study contacts

  • Principal investigator: YUKIO OZAKI, MD, PhD — Fujita Health University, Aichi, Japan
  • Study coordinator: YUKIO OZAKI, MD, PhD
  • Email: yukio.ozaki7@gmail.com
  • Phone: 08030713131

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.