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
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
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
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
