UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042883 |
|---|---|
| Receipt number | R000048945 |
| 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 | 2021/01/01 |
| Last modified on | 2021/01/01 22:07:23 |
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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 Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
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 Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
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
The relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and coronary plaque characteristics by CCTA in the same 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
Patients who were suspected of having coronary artery disease by 64-slice MDCT before percutaneous coronary intervention (PCI) at our institution
Key exclusion criteria
1. Chronic kidney disease manifested by an estimated glomerular filtration rate of < 40 mL/min/1.73 m2
2. Significant left main disease
3. Previously stented lesions. In addition, patients with extensively severe stenotic lesions which was anticipated difficulty in advancing the NIRS-IVUS catheter without plain old balloon angioplasty (POBA) using more than 2.0 mm of diameter were excluded.
4. Extremely calcified lesions treated with atheroablative device (e.g. Rotablator and Diamondback 360).
Target sample size
120
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, 500-8384, JAPAN
TEL
+81-58-277-2277
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
5008384
Address
4-14-4 Yabuta-minami, Gifu-city, Gifu, 500-8384, JAPAN
TEL
+81-58-277-2277
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, 500-8384, JAPAN
Tel
+81582772277
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 | 01 | 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
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 06 | 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
The relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and coronary plaque characteristics by CCTA in the same lesions
Management information
Registered date
| 2021 | Year | 01 | Month | 01 | Day |
Last modified on
| 2021 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048945
