UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054067 |
|---|---|
| Receipt number | R000061732 |
| Scientific Title | CT-Angiography-Derived Plaque Characteristics and Cardiovascular Events in Deferral Patients by Invasive Fractional Flow Reserve |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/04 23:01:01 |
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Basic information
Public title
CT-Angiography-Derived Plaque Characteristics and Cardiovascular Events in Deferral Patients by Invasive Fractional Flow Reserve
Acronym
CAPTURE
Scientific Title
CT-Angiography-Derived Plaque Characteristics and Cardiovascular Events in Deferral Patients by Invasive Fractional Flow Reserve
Scientific Title:Acronym
CAPTURE
Region
| Japan |
Condition
Condition
chronic coronary syndromes (CCS)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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. We hypothesized that CTA might 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, we examine clinical features and plaque characteristics on CTA in the deferral lesions based on invasive FFR in consecutive patients with chronic coronary syndromes (CCS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Cardiac events were defined as a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-based analysis. Cardiac events were redefined as lesion-level ACS and lesion-level ischemia-driven revascularization.
Key secondary outcomes
Secondary endpoints are the individual components of the primary endpoints.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of this study are as follows 1) men and women aged over 20 years, 2) patients having CCS, 3) CTA was performed within 90 days before invasive coronary angiography with FFR pressure measurement.
Key exclusion criteria
The exclusion criteria are 1) patients with a history of coronary bypass grafting (CABG) because CABG changed local coronary flow dynamics, 2) patients with left-main disease, and 3) patients with FFR in stented vessels due to inability to estimate plaque morphology in the stented lesion by CTA.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | YUKIO |
| Middle name | |
| Last name | OZAKI |
Organization
Fujita Health University (FHU) Hospital, FHU Bantane Hospital, and Nagoya First Red Cross Hospital
Division name
Cardiology
Zip code
470-1192
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
TEL
+819015609030
yukio.ozaki7@gmail.com
Public contact
Name of contact person
| 1st name | YUKIO |
| Middle name | |
| Last name | OZAKI |
Organization
Fujita Health University School of Medicine
Division name
Cardiology
Zip code
470-1192
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
TEL
+819015609030
Homepage URL
yukio.ozaki7@gmail.com
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
YUKIO OZAKI
Funding Source
Organization
Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University School of Medicine
Address
1-98 Dengaku, Kutsukake, Toyoake, Japan 470-1192
Tel
+819015609030
yukio.ozaki7@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤田医科大学病院(愛知県)、藤田医科大学坂種病院(愛知県)、名古屋第一赤十字病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Not yet
Publication of results
Unpublished
Result
URL related to results and publications
Not yet
Number of participants that the trial has enrolled
373
Results
Now we analyse the data.
Results date posted
| 2024 | Year | 04 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Study entry was delayed due to COVID-19 pandemic.
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
No particular difference is seen in the two groups.
Participant flow
Consecutive series of patients are enrolled.
Adverse events
Cardiac events are defined as a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-based analysis. Cardiac events are redefined as lesion-level ACS and lesion-level ischemia-driven revascularization.
Outcome measures
Cardiac events are defined as a composite of cardiac death, non-fatal acute coronary syndrome (ACS), and ischemia-driven revascularization for patient-based analysis. Cardiac events are redefined as lesion-level ACS and lesion-level ischemia-driven revascularization. We analyse the data now.
Plan to share IPD
We do not have the plan now.
IPD sharing Plan description
We do not have the plan now.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Clinical follow-up was performed in all the patients (follow-up rate 100%).
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061732
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