UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030497
Receipt No. 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 (Ver. 7)

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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
Email 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
Email tomizawa-tky@umin.ac.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034816