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Clinical Trials in Japan / NCT06508697
Recruiting Observational

CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve

NCT06508697 · tracked via the Priya Life Science Japan tracker
Sponsor
Fujita Health University
Phase
Observational
Started
2025-01-30
Last updated
2025-01-03

Condition(s) studied

Patient Preference

Investigational drug(s) / intervention(s)

invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement

invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement: A consecutive series of patients who underwent Coronary computed tomography angiography (CTA) within 90 days before invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement were candidates for this study at Fujita Health University Hospital, Bantane Hospital, and Nagoya First Red Cross Hospital

Study summary

Fractional flow reserve (FFR)-guided PCI for chronic coronary syndromes (CCS) is reported to improve the outcomes compared with angiography-guided PCI. However, cardiac-events still occur in FFR-deferral patients in long-term follow-up. Coronary computed tomography angiography (CTA)-defined high-risk-plaque (HRP) is known to relate future cardiac events. The investigators hypothesized that CTA might identify plaque features linked to future cardiac events in deferral patients.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Cardiac events in patient level — From 2018 to 2026
    a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-level analysis
  • Cardiac events in lesion level — From 2018 to 2026
    lesion-level ACS and lesion-level ischemia-driven revascularization

Trial sites (1)

FacilityCityRegionStatus
Fujita Health University Toyoake Aichi-ken Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06508697 on ClinicalTrials.gov ↗ ← All trials in Japan