Patient PreferenceCAPTURENCT06508697
CT-Angiography Plaque Characteristics and Events in Deferral Patients by Invasive Fractional Flow Reserve
An observational study of Patient Preference, run by Fujita Health University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patient Preference
- What is being tested?
- invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- 30 Jan 2025to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Yukio Ozaki, MD, PhD, +81562932312, ozakiyuk@fujita-hu.ac.jp
YUKIO OZAKI, MD, Phd, +818030713131, yukio.ozaki7@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Patient Preference
- Being tested
- invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurementDiagnostic test
Also called Coronary computed tomography angiography (CTA)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac events in patient level
a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-level analysis
Measured: From 2018 to 2026
Cardiac events in lesion level
lesion-level ACS and lesion-level ischemia-driven revascularization
Measured: From 2018 to 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start30 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PreferenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fujita Health University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Ozaki, Fujita Health University
- Investigators
- YUKIO OZAKI, MD, PhD, Principal investigator, Fujita Health University, Aichi, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508697
- Sponsor's protocol ID
- CI20-015
- Acronym
- CAPTURE
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Angiography-Derived Plaque Characteristics on Cardiac Events in Deferral Patients by Invasive Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT06508697
- Acronym / sponsor ID
- CAPTURE / CI20-015
- Conditions
- Patient Preference
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fujita Health UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent CTA within 90 days before ICA with FFR pressure | – | Diagnostic Test: invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurementA 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| invasive coronary angiography (ICA) with fractional flow reserve (FFR) pressure measurementAlso: Coronary computed tomography angiography (CTA)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 | Patients who underwent CTA within 90 days before ICA with FFR pressure |
Primary outcome
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
Cardiac events in lesion level
Time frame: From 2018 to 2026
lesion-level ACS and lesion-level ischemia-driven revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YUKIO OZAKI, MD, PhD principal investigator
Fujita Health University, Aichi, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Preference, run by Fujita Health University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YUKIO OZAKI, MD, PhD (08030713131, yukio.ozaki7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac events in patient level (time frame: From 2018 to 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.