UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034030 |
|---|---|
| Receipt number | R000038480 |
| Scientific Title | Coronary Plaque Monitoring using Coronary CT Angiography: Variability of CT Scanners and Observers |
| Date of disclosure of the study information | 2018/10/05 |
| Last modified on | 2023/03/09 14:34:21 |
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Basic information
Public title
Coronary Plaque Monitoring using Coronary CT Angiography: Variability of CT Scanners and Observers
Acronym
Coronary Plaque Monitoring using Coronary CT Angiography
Scientific Title
Coronary Plaque Monitoring using Coronary CT Angiography: Variability of CT Scanners and Observers
Scientific Title:Acronym
Coronary Plaque Monitoring using Coronary CT Angiography
Region
| Japan |
Condition
Condition
Coronary artery stenosis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose this study is to determine CT scan variability for measurement of coronary plaque volume and inter-observer agreement and variability for coronary CT findings of vulnerable plaque.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints of this study are,
1. The sample size required by coronary CT angiography to show a clinical change with 90% power and an a error of .05. based on intraclass correlation coefficients.
2. Variability and agreement of CT findings of vulnerable plaque.
Key secondary outcomes
The secondary endpoints of this study are,
1. Radiation dose for coronary CTA.
2. Reproducibility of coronary calcium score
3. Reproducibility of diameter stenosis
4. Reproducibility of wall volume
5. Reproducibility of lumen volume
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
| 20 | years-old | < |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Provide informed consent
2. CAD with an anatomical stenosis 30% or more, diagnosed on coronary CT angiography
3. stable symptom
Key exclusion criteria
1. Age of <20 or >=85 yrs.
2. Need for early revascularization
3. History of coronary stent or bypass
4. Agatston score >1000
5. Renal dysfunction (eGFR <45 mg/dl/1.73m2)
6. Estimated radiation exposure of 15 mSv or more within 1 yr. at the time of registration.
7. Contraindication for iodine contrast medium
8. Suspected pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Takagi |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
020-8505
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
hdnb69tkg@gmail.com
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Takagi |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
020-8505
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
Homepage URL
hdnb69tkg@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee at Iwate Medical University Hospital.
Address
Uchimaru, Morioka
Tel
019-651-5111
kenkyu@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
| 2018 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
23
Results
NA
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
In this study, we will prospectively enroll patients who demonstrate >=30% stenosis on coronary CT angiography. Participants enrolled undergo 2nd coronary CT angiography within 90 days after 1st coronary CT angiography.
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038480
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
