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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009173
Receipt No. R000010764
Scientific Title Usefulness of a Bolus Injection of Landiolol for Multidetector Computed Tomographic Angiography
Date of disclosure of the study information 2012/10/23
Last modified on 2012/10/23

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Basic information
Public title Usefulness of a Bolus Injection of Landiolol for Multidetector Computed Tomographic Angiography
Acronym Landiolol for Computed Tomographic Angiography
Scientific Title Usefulness of a Bolus Injection of Landiolol for Multidetector Computed Tomographic Angiography
Scientific Title:Acronym Landiolol for Computed Tomographic Angiography
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify usefulness of a Bolus Injection of Landiolol for Multidetector Computed Tomographic Angiography
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The image quality score of each coronary vessels and that on the per patient basis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 premedication of oral propranolol 10mg was administered one and half hour before the CTA for patients with body weight < 70kg while propranolol 20mg was administered for patients with body weight &#8805; 70 kg.
Interventions/Control_2 Intravenous 0.125mg/kg of landiolol was administered
Interventions/Control_3 Intravenous 0.125mg/kg of landiolol was administered for patients with HR < 75/min, while 0.125mg/kg and additional 3.75mg were administered for patients with HR &#8805; 75/min
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patient who underwent CT angiography.
Key exclusion criteria CTA for evaluating bypass graft or ascending aorta, HR before administration < 60/min or > 90/min, atrial fibrillation, pacemaker implanted, history of vasospastic angina, advanced atrioventricular block, left ventricular ejection fraction < 40%, systolic blood pressure < 90mmHg, and known drug allergy. During the enrollment period of propranolol, those who had a history of asthma were also excluded.
Target sample size 1094

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyohei Yamaji
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address Kitakyushu-shi Kokurakita-ku Asano 3-2-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyohei Yamaji
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address
TEL
Homepage URL
Email kyohei@yamaji.info

Sponsor
Institute Kokura Memorial Hospital
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)

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
2012 Year 10 Month 23 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 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 16 Day
Date of closure to data entry
2012 Year 03 Month 16 Day
Date trial data considered complete
2012 Year 03 Month 16 Day
Date analysis concluded
2012 Year 10 Month 23 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 23 Day
Last modified on
2012 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010764

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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