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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004782
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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