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

NCT06508697 | Recruiting

• 1 other identifier: CI20-015
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Preference

Outcome Measures

Primary Outcomes (2)

• Cardiac events in patient level

  a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-level analysis

  From 2018 to 2026

• Cardiac events in lesion level

  lesion-level ACS and lesion-level ischemia-driven revascularization

  From 2018 to 2026

Study Arms (1)

Patients who underwent CTA within 90 days before ICA with FFR pressure

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.

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

Interventions

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

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

Also known as: Coronary computed tomography angiography (CTA)

Patients who underwent CTA within 90 days before ICA with FFR pressure

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A consecutive series of 437 patients who underwent CTA within 90 days before ICA with FFR pressure measurement were candidates for this study at Fujita Health University Hospital, Bantane Hospital, and Nagoya First Red Cross Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujita Health University: lead

Study Sites (1)

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• YUKIO OZAKI, MD, PhD

  Fujita Health University, Aichi, Japan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YUKIO OZAKI, MD, PhD

CONTACT

08030713131; yukio.ozaki7@gmail.com

REINA OZAKI, MD

CONTACT

09078631882; reina.ozaki1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 18, 2024
• Study Start: January 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-07

Locations

JP (1)