Actively Recruiting

Age: 20Years +
All Genders
ID06508697

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

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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