UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048311 |
|---|---|
| Receipt number | R000054960 |
| Scientific Title | Near-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study |
| Date of disclosure of the study information | 2022/07/11 |
| Last modified on | 2025/01/14 16:58:56 |
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Basic information
Public title
Near-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study
Acronym
STRATIFY-NIRS
Scientific Title
Near-infrared spectroscopy and intravascular ultrasound for risk stratification of coronary stenosis with deferred revascularization based on fractional flow reserve: The STRATIFY-NIRS study
Scientific Title:Acronym
STRATIFY-NIRS
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of lipid rich plaque as assessed by NIRS-IVUS in deferred coronary arteries by FFR among ACS patients and its impact on prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target vessel failure (cardiac death, target-vessel myocardial infarction, clinically-driven target vessel revascularization) at 2 years
Key secondary outcomes
TVF at 1, 3, 4, 5 years
Death at 1, 2, 3, 4, 5 years
Cardiac death at 1, 2, 3, 4, 5 years
Non-cardiac death at 1, 2, 3, 4, 5 years
MI at 1, 2, 3, 4, 5 years
Target-vessel MI at 1, 2, 3, 4, 5 years
Revascularization at 1, 2, 3, 4, 5 years
Clinically-driven revascularization at 1, 2, 3, 4, 5 years
Target vessel revascularization at 1, 2, 3, 4, 5 years
Clinically-driven target vessel revascularization at 1, 2, 3, 4, 5 years
Target lesion revascularization at 1, 2, 3, 4, 5 years
Clinically-driven target lesion revascularization at 1, 2, 3, 4, 5 years
Stroke at 1, 2, 3, 4, 5 years
Bleeding at 1, 2, 3, 4, 5 years
Secondary imaging outcome measures:
Correlation among FFR value, plaque burden by IVUS, MLA by IVUS, and LCBI.
Correlation among plaque burden by IVUS, MLA by IVUS, and LCBI by NIRS-IVUS, plaque burden by CT, plaque type by CT, and diameter stenosis by CT.
Correlation among PPG (pullback pressure gradient), plaque burden by IVUS, MLA by IVUS, and LCBI.
Sub-group analysis:
MaxLCBI4mm 400
MaxLCBI4mm median value
Plaque burden >=70%
Minimal lumen area <=4.0 mm2
Hemodialysis
PCI indication (STEMI vs. NSTEMI vs. UAP)
Ischemic risk
Diabetes
Sub categories of FFR value (FFR0.81-0.85, 0.86-0.90, 0.91-1.00)
Diameter stenosis, CT value <30 HU, positive remodeling, spotty calcification, napkin ring sign as assessed by coronary CT
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
| 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.
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
400
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-3352
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-3352
Homepage URL
yasushi522@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University ethics committee
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
Tel
0263-37-2572
md_rinri@shinshu-u.ac.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
| 2022 | Year | 07 | Month | 11 | 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
| 2022 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 06 | 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
| 2022 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054960
