UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011817 |
|---|---|
| Receipt number | R000013793 |
| Scientific Title | Radiation-Dose-Lowering Effect of Landiolol Hydrochloride in Coronary Angiography Using Computed Tomography (DELIGHT): A Prospective Multicenter Study |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2016/04/19 10:58:10 |
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Basic information
Public title
Radiation-Dose-Lowering Effect of Landiolol Hydrochloride in Coronary Angiography Using Computed Tomography (DELIGHT): A Prospective Multicenter Study
Acronym
Radiation-Dose-Lowering Effect of Landiolol Hydrochloride in Coronary Angiography Using Computed Tomography (DELIGHT): A Prospective Multicenter Study
Scientific Title
Radiation-Dose-Lowering Effect of Landiolol Hydrochloride in Coronary Angiography Using Computed Tomography (DELIGHT): A Prospective Multicenter Study
Scientific Title:Acronym
Radiation-Dose-Lowering Effect of Landiolol Hydrochloride in Coronary Angiography Using Computed Tomography (DELIGHT): A Prospective Multicenter Study
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective multicenter study was to assess the effectiveness of the new short-acting intravenous Beta 1-receptor blocker, landiolol hydrochloride, in reducing the radiation dose to patients undergoing Coronary CT Angiograph (CCTA) with the latest scanners.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We compare exposed dose at CT angiography and the estimated exposure dose by the heart rate just before medication.
Key secondary outcomes
1) exposed dose at CCTA
2) ratio of the patients who could use prospective gating mode at CT angiograph
3) heart rate, blood pressure
4) assessability of the CCTA
5) adverse events, side effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
0.125 mg/kg of landiolol hydrochloride was injected for 60 s.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who has the necessity for the heart rate reduction by beta blocking agent medication with 80 bpm or less heart rate just before administration.
Key exclusion criteria
1)Patients with an implantable cardiac pacemaker or an implantable cardioverter-defibrillator
2)Patients who was previously treated with coronary artery bypass grafting
3)Patients with cardiomyopathy
4)Patients with a valve disease
5)Patients with an advanced bradycardia (heart rate less than 50 bpm)
6)Patients with blood pressure less than 110 mmHg at the time into the CT room
7)Patients with atrial fibrillation or premature beat, and expected them during the CTA
8)Patients with contraindication of landiolol hydrochloride
9)Patients with contraindication of nonionic contrast media
10)Patients with relative contraindication of nonionic contrast media and examination doctor judged to be unsuitable for incorporating
11)Patients who had severe allergy experience
12)Patients under pregnancy and breast-feeding and with the possibility of pregnancy, or the patient who wishes to become pregnant during examination period
13)Patients who examination doctor judged to be unsuitable for incorporating because of another reason
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachio Kuribayashi |
Organization
Keio University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582,Japan
TEL
+81-3-3353-1211
skuribay@med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruhito Kido |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
Address
Shitsukawa, Toon city, Ehime 791-0295, JAPAN
TEL
+81-89-960-5371
Homepage URL
terukido@m.ehime-u.ac.jp
Sponsor or person
Institute
DELIGHT study group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
・岩手医科大学循環器医療センター循環器放射線科（岩手県）
・愛媛大学大学院放射線医学（愛媛県）
・慶應義塾大学医学部放射線診断科（東京都）
・国立循環器病研究センター放射線部（大阪府）
・東京医科大学循環器内科（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013793
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