UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050751 |
|---|---|
| Receipt number | R000057282 |
| Scientific Title | 18F-sodium fluoride positron emission tomography and near-infrared spectroscopy intravascular ultrasound for evaluation of coronary artery plaques in stenosis with deferred revascularization based on fractional flow reserve |
| Date of disclosure of the study information | 2023/04/02 |
| Last modified on | 2023/04/02 23:04:14 |
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Basic information
Public title
18F-sodium fluoride positron emission tomography and near-infrared spectroscopy intravascular ultrasound for evaluation of coronary artery plaques in stenosis with deferred revascularization based on fractional flow reserve
Acronym
18F-NaF PET and NIRS-IVUS for evaluation of coronary plaques
Scientific Title
18F-sodium fluoride positron emission tomography and near-infrared spectroscopy intravascular ultrasound for evaluation of coronary artery plaques in stenosis with deferred revascularization based on fractional flow reserve
Scientific Title:Acronym
18F-NaF PET and NIRS-IVUS for evaluation of coronary plaques
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate coronary plaques by 18F-NaF PET and NIRS-IVUS in coronary artery stenosis with deferred revascularization based on FFR > 0.80 in patients with ACS and its impact on prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare 18F-sodium fluoride uptake of coronary artery on PET with NIRS-IVUS findings (e.g. maxLCBI(4mm)).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
After NIRS-IVUS for coronary arteries with FFR > 0.80, NaF-PET/CT of coronary plaque is performed within 1 month. For PET/CT, approximately 200 MBq of 18F-NaF is administered intravenously, and low-dose CT and PET images are taken 60 minutes later on a PET/CT scanner.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients >=18 years of age.
2. Patients with ACS undergoing PCI within 4 weeks before study enrollment.
3. Patients with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography) in non-culprit coronary artery, assessed using NIRS-IVUS additionally.
Key exclusion criteria
1. Target vessels* previously treated by PCI.
2. Target vessels* with significant coronary calcification or tortuosity deemed to preclude NIRS-IVUS evaluation.
3. Target vessels* with reference lumen diameter <=2mm.
4. History of CABG.
5. Unstable clinical status (hemodynamic or electrical instability).
6. Patients unwilling or unable to provide informed consent.
7. Life expectancy is less than 1 year at study enrollment.
8. Patients considered unsuitable for the study at the discretion of the operator.
*Target vessel is defined as a non-culprit coronary artery with deferred coronary lesions by FFR (i.e. FFR>0.80) with a moderate stenosis (visual estimation of diameter stenosis >=50%, <90% by coronary angiography).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Senda |
Organization
Aizawa Hospital
Division name
Department of Cardiology
Zip code
390-8510
Address
2-5-1 Honjo, Matsumoto, Nagano, Japan
TEL
0263-33-8600
k_senda@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Senda |
Organization
Aizawa Hospital
Division name
Department of Cardiology
Zip code
390-8510
Address
2-5-1 Honjo, Matsumoto, Nagano, Japan
TEL
0263-33-8600
Homepage URL
k_senda@shinshu-u.ac.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jisenkai IRB
Address
2-5-1 Honjo, Matsumoto, Nagano, Japan
Tel
0263-33-8600
kenkyu@i-hosp.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be followed-up up to 5 years.
Management information
Registered date
| 2023 | Year | 04 | Month | 02 | Day |
Last modified on
| 2023 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057282
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| Registered date | File name |
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| Registered date | File name |
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