UMIN-CTR Clinical Trial

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
Email	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
Email	terukido@m.ehime-u.ac.jp

Sponsor
Institute	DELIGHT study group
Institute
Department

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
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	・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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013793

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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