UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015198 |
|---|---|
| Receipt number | R000017665 |
| Scientific Title | The effect of pre-landiololtreatment on ischemic reperfusion injury in acute myocardial infarction trial |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2018/06/28 09:26:58 |
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Basic information
Public title
The effect of pre-landiololtreatment on ischemic reperfusion injury in acute myocardial infarction trial
Acronym
PROTECTION trial
Scientific Title
The effect of pre-landiololtreatment on ischemic reperfusion injury in acute myocardial infarction trial
Scientific Title:Acronym
PROTECTION trial
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of landiolol on ischemic reperfusion in patients with acute myocardial infarction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myocardial salvage index determined with MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous landiolol injection
Interventions/Control_2
saline injection
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
patients with acute myocardial infarction within 12 hours after onset
Key exclusion criteria
(a) Killip class III or IV
(b) systolic BP less than 120 mmHg
(c)PR duration over 240 ms
(d)AV block (grade II ro III)
(e)heart rate less than 60bpm
(f)Patients receiving oral beta blockers
(g) LVEF less than 30%
(h) Patients having allergy against landiolol and/or nitrates
(i)patients receiving any unapproved drugs for clinical study within 6 months
(j)Pregnant
(k)patients having any disease which is less than 12 months of prognosis
(l)Diabetic ketoacidosis or metabolic ketoacidosis
(m)Prior myocadial infarction
(n)patients wiht pacemaker or ICD
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama University
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama Univeersity
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama Univeersity
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 09 | Month | 17 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
