UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030497 |
|---|---|
| Receipt number | R000034816 |
| Scientific Title | Decreasing the amount of contrast medium during aortic CT angiography |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2020/03/25 21:44:22 |
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Basic information
Public title
Decreasing the amount of contrast medium during aortic CT angiography
Acronym
Aortic CTA by double ROI timing bolus method
Scientific Title
Decreasing the amount of contrast medium during aortic CT angiography
Scientific Title:Acronym
Aortic CTA by double ROI timing bolus method
Region
| Japan |
Condition
Condition
Aortic aneurysm, aortic dissection
Classification by specialty
| Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether the amount of contrast medium necessary for aorta CT angiography acquisition could be reduced using the timing bolus method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To test whether the attenuation of the aorta would improve in spite of reducing the amount of contrast medium.
Key secondary outcomes
Subjective analysis of the aorta and its branches.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Perform CT angiography of the aorta with 40 ml of contrast medium.
From Jul 25, 2018, the amount of contrast medium will be adjusted by the time density curve and the tube voltage.
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 suspected of aortic aneurysm or dissection.
Key exclusion criteria
1. Severe renal dysfunction
2. Allergy to contrast medium
3. Unable to place a 20-gauge catheter
4. Peak enhancement <100 HU during test scan or peak not detectable
(From Jul 25, 2018, the amount of contrast medium would be increased when the peak enhancement is low.)
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Tomizawa |
Organization
New Tokyo Hospital
Division name
Department of Radiology
Zip code
2702232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
+81-477118700
tomizawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Tomizawa |
Organization
New Tokyo Hospital
Division name
Department of Radiology
Zip code
2702232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
+81-477118700
Homepage URL
tomizawa-tky@umin.ac.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
IRB of New Tokyo Hospital
Address
1271 Wanagaya, Matsudo, Chiba
Tel
+81477118700
t-akutsu@sth-medical.co.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
| 2017 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
272
Results
1. Tomizawa N, Ito S, Nakao T, Arakawa H, Yamamoto K, Inoh S, Nojo T, Nakamura S. Double ROI Timing Bolus Technique to Perform Aortic CT Angiography With a 9-Second Contrast Injection Duration. Am J Roentgenol 2019;213(1):96-103
2. Tomizawa N, Ito S, Nakao T, Arakawa H, Yamamoto K, Inoh S, Nojo T, Nakamura S. Aortic CT Angiography Using the Double Region of Interest Timing Bolus Technique: Feasibility of 80 kVp Scanning in Lean Patients. Int J Cardiovasc Imaging 2019;35(11):2113-2121
Results date posted
| 2020 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Suspected of aortic disease
Participant flow
Patients who are clinically indicated for aortic CTA were recruited.
Adverse events
None
Outcome measures
1. Aortic enhancement
2. Image quality of the aorta
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034816
