UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of heart rate control with beta-blocker in the acute phase of myocardial infarction on hemodynamic and functional outcomes.
Title of the study (Brief title)	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	KATSUOMI IWAKURA
Organization	Sakurabashi Watanabe Hospital
Division name	Division of Cardiovascular Medicine
Address	2-4-32, Umeda, Kita-ku, Osaka, Japan
TEL	06(6341)8651
Email

Public contact
Name of contact person	YOHEI SOTOMI
Organization	Sakurabashi Watanabe Hospital
Division name	Division of Cardiovascular Medicine
Address	2-4-32, Umeda, Kita-ku, Osaka, Japan
TEL	06(6341)8651
Homepage URL
Email

Sponsor
Institute	Sakurabashi Watanabe 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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005677