UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004782
Receipt number R000005677
Scientific Title The effect of heart rate control with beta-blocker in the acute phase of myocardial infarction on hemodynamic and functional outcomes.
Date of disclosure of the study information 2010/12/24
Last modified on 2017/10/24 12:48:36

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Basic information

Public title

The effect of heart rate control with beta-blocker in the acute phase of myocardial infarction on hemodynamic and functional outcomes.

Acronym

The effect of heart rate control in the acute phase of myocardial infarction on hemodynamic and functional outcomes.

Scientific Title

The effect of heart rate control with beta-blocker in the acute phase of myocardial infarction on hemodynamic and functional outcomes.

Scientific Title:Acronym

The effect of heart rate control in the acute phase of myocardial infarction on hemodynamic and functional outcomes.

Region

Japan


Condition

Condition

Acute Myocardial Infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of heart rate control with beta-blocker for hemodynamic and cardiac function in the acute phase of myocardial infarction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

(1) estimated infarct size
(2) left ventricular function (left ventricular ejection fraction )
(3)incidence of arrhythmia
(especially atrial fibrillation , ventricular tachycardia and ventricular fibrillation).

Key secondary outcomes

(1) survival rate
(2) reperfusion injury (ie, malignant ventricular arrhythmia , re-elevation of ST-segment and worsening of chest pain after reperfusion)
(3)cardiovascular events (ie, cardiac death, nonfatal infarction, re-hospitalization because of cardiac disease, revascularization)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Landiolol,Carvedilol

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

(1)first episode of myocardial infarction
(2)ST-elevation myocardial infarction
(3)admission to hospital within 12 hours of symptom onset
(4) heart rate greater than 90 beats/min on admission
(5) emergent primary percutaneous coronary intervention

Key exclusion criteria

(1)cardiogenic Shock
(2)severe deterioration of liver function
(3)history of beta-blocker or amiodarone treatment
(4)history of side effects or contraindication of beta-blocker
(5)hypersensitivity to trial medicine
(6)doctor's decision not to register to this regimen

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name KATSUOMI IWAKURA

Organization

Sakurabashi Watanabe Hospital

Division name

Division of Cardiovascular Medicine

Zip code


Address

2-4-32, Umeda, Kita-ku, Osaka, Japan

TEL

06(6341)8651

Email



Public contact

Name of contact person

1st name
Middle name
Last name YOHEI SOTOMI

Organization

Sakurabashi Watanabe Hospital

Division name

Division of Cardiovascular Medicine

Zip code


Address

2-4-32, Umeda, Kita-ku, Osaka, Japan

TEL

06(6341)8651

Homepage URL


Email



Sponsor or person

Institute

Sakurabashi Watanabe 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

2010 Year 12 Month 24 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

Terminated

Date of protocol fixation

2010 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 24 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

2010 Year 12 Month 22 Day

Last modified on

2017 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name