UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015380
Receipt number R000017831
Scientific Title A retrospective study of efficacy of landiolol hydrochloride for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery
Date of disclosure of the study information 2014/10/09
Last modified on 2017/03/24 11:33:33

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Basic information

Public title

A retrospective study of efficacy of landiolol hydrochloride for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery

Acronym

A retrospective study of efficacy of landiolol hydrochloride for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery

Scientific Title

A retrospective study of efficacy of landiolol hydrochloride for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery

Scientific Title:Acronym

A retrospective study of efficacy of landiolol hydrochloride for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery

Region

Japan


Condition

Condition

Patients with left ventricular dysfunction undergoing off-pump coronary artery bypass surgery

Classification by specialty

Cardiology Vascular surgery Anesthesiology
Cardiovascular surgery Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of landiolol for patients with left ventricular dysfunction undergoing off-pump coronary artery bypass.
To evaluate short turm prognosis for patients with left ventricular dysfunction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of prognosis in patients with left ventricular dysfunction with and without landiolol use during surgery
Comparison of short turm prognosis in patients with left ventricular dysfunction

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1.Patients who underwent off-pump coronary artery bypass surgery

Key exclusion criteria

1.No preoperative echocardiographic examination
2.No preoperative Doppler echocardiographic examination
3.Patients ineligible to the study based on investigator's judgment

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Go Kusumoto

Organization

Fukuoka University Hospital

Division name

Department of Anesthesiology

Zip code


Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

092-801-1011

Email

kusumoto@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Go Kusumoto

Organization

Fukuoka University Hospital

Division name

Department of Anesthesiology

Zip code


Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

092-801-1011

Homepage URL


Email

kusumoto@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University Hospital

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)



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

2014 Year 10 Month 09 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

2014 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective chart reviews


Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2017 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name