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

January 2, 2025 updated by: Yukio Ozaki, Fujita Health University

CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Deferral Patients by Invasive Fractional Flow Reserve

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although fractional flow reserve (FFR)-guided percutaneous-coronary-intervention (PCI) has improved short- and middle-term outcome compared with angiography-guided PCI alone, cardiac-events still occur in FFR-deferral patients in long-term.1-4 Recent J-CONFIRM registry examined 1263 patients with 1447 lesions in whom revascularization was deferred based on FFR in the 28 centers.5 While 2-year target vessel failure (TVF) rate was 5.5% in deferred lesions in the J-CONFIRM registry, 5-year TVF raised up 11.6% in deferred lesions.5, 6 The TVF rate raised up from 5.5% to 11.6% in the last 3 years mainly due to clinically driven target-vessel-revascularization (TVR) in the registry.5, 6 In the DEFER trial, patients with FFR > 0.75 were randomly assigned to PCI deferral (Defer) or performance (Perform) and patients showing FFR < 0.75 underwent PCI (Reference).3 The 5-year cardiac death and acute myocardial infarction (AMI) rate were excellent in the Defer group as compared to Perform and Reference groups (3.3%, 7.9%, and 15.7%, p < 0.003, respectively).4 However, 15-year follow-up of the DEFER study revealed that all cause of mortality and TVR were similar among Defer, Perform and Reference groups (mortality; 33.0% vs. 31.1% vs. 36.1% p= 0.441 respectively, and TVR; 36.3% vs. 27.8% vs. 35.4%, p= 0.522 respectively).7 Favorable initial 5-year clinical outcome in deferral patients has been lost during 15-year follow-up in the DEFER study. It is urgent issue to disclose the factor to predict future cardiac events in deferral lesions. The failure of PCI to modify long-term outcomes may stem from its inability to modify the underlying atherosclerotic process.

Furthermore, recent PREVENT study disclosed that in patients with non-flow-limiting (FFR >0.80) vulnerable coronary plaques identified by intracoronary imaging, preventive PCI reduced major adverse cardiac events (MACE) arising from high-risk vulnerable plaques, compared with optimal medical therapy (OMT) alone8. Although their high-risk vulnerable plaques were defined using intracoronary imaging but not coronary CT angiography (CTA) in the PREVENT study, the presence of high-risk vulnerable plaque without flow-limiting (FFR >0.80) frequently caused the subsequent cardiac events in patients without the initial PCI.

While CTA is known to be useful to evaluate coronary artery plaque features as well as stenosis severity, high-risk plaque (HRP) on coronary CTA defined as a combination of positive remodeling (PR) and low attenuation plaque (LAP) has been reported to be associated with the future cardiac events.9-12 Gallone and coworkers reported in their meta-analysis that high-risk coronary plaque characteristics significantly predicted patient-level and lesion-level major adverse cardiac event (MACE) in the future, using various high-risk coronary plaque definitions by several intracoronary imaging modalities and CTA.13 The investigators hypothesized that CTA could identify plaque features linked to future cardiac events in deferral patients. To determine the predictive factors for future cardiac events in FFR-based deferral patients, the investigators examined clinical features and plaque characteristics on CTA in the deferral lesions based on invasive FFR in consecutive 373 patients with chronic coronary syndromes (CCS).

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Aichi
      • Toyoake, Aichi, Japan, 470-1192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • Coronary computed tomography angiography (CTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac events in patient level
Time Frame: From 2018 to 2026
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
Time Frame: From 2018 to 2026
lesion-level ACS and lesion-level ischemia-driven revascularization
From 2018 to 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: YUKIO OZAKI, MD, PhD, Fujita Health University, Aichi, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CI20-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patient Preference

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

Search Similar Trials