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Recruitment status Completed
Unique ID issued by UMIN UMIN000015198
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama Univeersity
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017665


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