UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043115 |
|---|---|
| Receipt number | R000046006 |
| Scientific Title | Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography |
| Date of disclosure of the study information | 2021/01/24 |
| Last modified on | 2021/01/24 16:35:57 |
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Basic information
Public title
Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Acronym
Coronary Plaque Characterization by NIRS: Association with CCTA
Scientific Title
Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Scientific Title:Acronym
Coronary Plaque Characterization by NIRS: Association with CCTA
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary lesions.
Key secondary outcomes
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. At least 18 years of age
2. De novo, native coronary artery lesions
3. Blood cardiac biomarker (Troponin-T) levels less than the local laboratory the upper limit of normal (ULN) before PCI
4. Both NIRS and OCT catheters use are not contra-indicated
5. The lesion received one stent during the initial procedure
Key exclusion criteria
1. Prior coronary revascularization therapy (PCI and/or CABG) to target vessel
2. STEMI within the past 24 hours
3. Simultaneously treated with multi-vesssel PCI on initial procedure
4. LMT case
5. Chronic kidney disease (serum creatinine on admission more than 1.5 mg/dl)
6. Presented with hemodynamic instability (cardiogenic shock)
7. Complex lesion which need to do balloon dilatation (more than 2.0mm balloon or debulking device before pre-procedural NIRS-IVUS
8. Poor image quality case which the technician cannot perform either CTA or NIRS-IVUS measurements
9. Lesions with an EEM diameter <2.0mm
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Matsuo |
Organization
Gifu Heart Center
Division name
Department of Cardiology
Zip code
500-8384
Address
4-14-4 Yabuta-minami, Gifu-city, Gifu
TEL
058-277-2277
matsuo@heart-center.or.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Ota |
Organization
Gifu Heart Center
Division name
Department of Cardiology
Zip code
500-8384
Address
4-14-4 Yabuta-minami, Gifu-city, Gifu
TEL
058-277-2277
Homepage URL
ota@heart-center.or.jp
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board, Gifu Heart Center
Address
4-14-4 Yabuta-minami, Gifu-city, Gifu
Tel
058-277-2277
ota@heart-center.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
| 2021 | Year | 01 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
111
Management information
Registered date
| 2021 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046006
