UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008472 |
|---|---|
| Receipt number | 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 12:11:53 |
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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
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
nishi24@jc4.so-net.ne.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009040
