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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008472
Receipt No. R000009040
Scientific Title Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.
Date of disclosure of the study information 2012/07/20
Last modified on 2012/07/19

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Basic information
Public title Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.
Acronym IDEAL study
Scientific Title Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.
Scientific Title:Acronym IDEAL study
Region
Japan

Condition
Condition Patients with preoperative EFs 40% or less who undergo cardiovascular operations using cariopulmonary bypass machine or Off Pump CABG (OPCAB) in the Department of Cardiovascular Surgery, Osaka University Hospital.
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether landiolol can also be safely used in patients with left ventricular dysfunction and is useful for the prevention of postoperative atrial fibrillation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes occurrence of postopeartive atrial fibrillation
Key secondary outcomes

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 administration of landiolol
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients without preoperative chronic atrial fibrillation.
Key exclusion criteria 1. Patients with cardiogenic shock
2. Patients with diabetic ketoacidosis and metabolic acidosis
3. Patients with bradycardia such as atrioventricular block (II degree or higher) and sick sinus syndrome
4. Patients with right heart failure due to pulmonary hypertension
5. Patients with congestive heart failure
6. Patients with untreated pheochromocytoma
7. Patients with a past history of hypersensitivity to landiolol
8. Patients with congenital heart diseases
9. Patients undergoing heart transplantation
10. Patients with ventricular assisted devices
11. Patients with ECMO
12. Patients having atrial fibrillation immediately before administration of landiolol
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2, Yamada-Oka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Email nishi24@jc4.so-net.ne.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
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 07 Month 20 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 Open public recruiting
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 19 Day
Last modified on
2012 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009040

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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