Examining plaque characteristics in patients deferred from coronary intervention
CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Deferral Patients by Invasive Fractional Flow Reserve
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 type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Fujita Health University Academic / other |
| Locations | 1 site (Toyoake, Aichi-ken) |
| Trial ID | NCT06508697 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toyoake, Aichi-ken
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.