UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056425 |
|---|---|
| Receipt number | R000064412 |
| Scientific Title | Comparison between Optical Coherence Tomography-Based and Intravascular Ultrasound-Based Calcium Scoring for Heavily Calcified Coronary Lesions |
| Date of disclosure of the study information | 2024/12/11 |
| Last modified on | 2024/12/11 17:13:56 |
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Basic information
Public title
Comparison between Optical Coherence Tomography-Based and Intravascular Ultrasound-Based Calcium Scoring for Heavily Calcified Coronary Lesions
Acronym
Comparison between Optical Coherence Tomography-Based and Intravascular Ultrasound-Based Calcium Scoring for Heavily Calcified Coronary Lesions
Scientific Title
Comparison between Optical Coherence Tomography-Based and Intravascular Ultrasound-Based Calcium Scoring for Heavily Calcified Coronary Lesions
Scientific Title:Acronym
Comparison between Optical Coherence Tomography-Based and Intravascular Ultrasound-Based Calcium Scoring for Heavily Calcified Coronary Lesions
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the differences in calcium scores between two different intravascular imaging modalities
Basic objectives2
Others
Basic objectives -Others
The objective of this study was to compare OCT- and IVUS-based calcium scores and diagnostic discrepancies for evaluating the heavily calcified lesion between both scoring systems
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordance rate between OCT-based and IVUS-based calcium score in the severe calcification (defined as a calcium score of 3 or higher).
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 treated for severe calcified lesions at the Department of Cardiology, Iwate Medical University Hospital, where imaging evaluation was performed using both (1) OCT (or OFDI) and (2) IVUS from Terumo or Boston Scientific.
Severe calcified lesions were defined as those requiring treatment with orbital atherectomy (OA), rotational atherectomy (RA), or intravascular lithotripsy (IVL).
Key exclusion criteria
Patients who was less than 18 years old.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Iwate Medical University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
maishida@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Iwate Medical University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
maishida@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.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
| 2024 | Year | 12 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The enrollment for the retrospective study has been completed, and it is currently under analysis.
Management information
Registered date
| 2024 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064412
