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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034030
Receipt No. 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 2019/04/20

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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
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Email hdnb69tkg@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL 019-651-5111
Homepage URL
Email hdnb69tkg@gmail.com

Sponsor
Institute Iwate Medical University
Institute
Department

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
Address
Tel
Email

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
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
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 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded

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
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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