Actively Recruiting
CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Patients Deferred by Invasive Fractional Flow Reserve
Led by Fujita Health University · Updated on 2025-01-03
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with chronic coronary syndromes (CCS) to understand how coronary computed tomography angiography (CTA) can identify plaque characteristics linked to future cardiac events in patients whose treatment was deferred based on invasive fractional flow reserve (FFR). Although FFR-guided percutaneous coronary intervention (PCI) has improved outcomes compared with angiography-guided PCI, cardiac events still occur long-term in patients whose PCI was deferred. The study focuses on the relationship between high-risk plaques seen on CTA and future cardiac events in these patients. This observational study includes patients who had a coronary CTA within 90 days before undergoing invasive coronary angiography (ICA) with FFR pressure measurement. The study examines clinical features and plaque characteristics on CTA in deferral lesions identified by FFR. Patients receive standard diagnostic testing including CTA and ICA with FFR, without additional treatments assigned by the study. Participants will be followed to track cardiac events at both the patient and lesion levels from 2018 to 2026. Researchers will review clinical data, imaging findings, and outcomes to identify plaque features associated with future cardiac events. The study does not involve treatment interventions but focuses on diagnostic imaging and long-term observation to better understand risk in this patient group.
CONDITIONS
Brief Title
CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 20 years or older
- Diagnosed with chronic coronary syndromes (CCS)
- Underwent coronary computed tomography angiography (CTA) within 90 days before invasive coronary angiography (ICA) with fractional flow reserve (FFR) measurement
You will not qualify if you...
- History of coronary bypass grafting (CABG)
- Presence of left-main coronary artery disease
- Fractional flow reserve (FFR) measured in stented vessels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants undergo coronary computed tomography angiography (CTA) followed by invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement to evaluate coronary plaque characteristics and blood flow.
1 to 2 visits within 90 days
Duration - From 2018 to 2026
Participants are monitored for cardiac events over several years following diagnostic evaluation to assess the relationship between plaque characteristics and future cardiac outcomes.
Periodic follow-up visits for up to 8 years
Trial Site Locations
Total: 1 location
1
Fujita Health University
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
Research Team
Y
YUKIO OZAKI, MD, PhD
R
REINA OZAKI, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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