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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030232
Receipt No. R000033660
Scientific Title Zinc supplementation for patients with acute myocardial infarction
Date of disclosure of the study information 2017/12/03
Last modified on 2019/03/31

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Basic information
Public title Zinc supplementation for patients with acute myocardial infarction
Acronym Zinc for MI
Scientific Title Zinc supplementation for patients with acute myocardial infarction
Scientific Title:Acronym Zinc for MI
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of zinc supplementation for patients with acute myocardial
infarction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Length of stay in the coronary care unit
Length of hospitalization stay
Infarct size, LVEF evaluated by MRI
Key secondary outcomes The rate of requiring specific ancillary devices such as a temporary pacemaker, intra-aortic balloon pump (IABP), invasive and non-invasive positive pressure ventilation or venoarterial extracorporeal membrane oxygenation (VA-ECMO)
LVEF, serum CK, CK-MB,BNP level
all-cause and cardiovascular mortality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Zinc acetate 25 mg twice dairy, 3 days
Conventional therapy
Interventions/Control_2 Conventional therapy
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 Age >20years
obtain written informed consent
success the primary PCI
Key exclusion criteria (1)Hepatic cirrhosis
(2)Dialysis
(3)Inflammatory bowel disease
(4)Chronic pancreatitis
(5)After enterectomy or pancreaticoduodenectomy
(6)Systemic inflammatory disease
(7)Sickle cell anemia
(8)Asthma, allergy of Gadolinium, MRI-none compatible pacemaker implanted
(9)allergy of Zinc acetate
(10) Patients with CTO in non-infarct related artery
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Toshitaka
Middle name
Last name Okabe
Organization Showa University Northern Yokohama Hospital
Division name Division of Cardiology and Cardiac Catheterization Labratories
Zip code 224-8503
Address 35-1, Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL 045-494-7000
Email alone_with_music@hotmail.com

Public contact
Name of contact person
1st name Toshitaka
Middle name
Last name Okabe
Organization Showa University Northern Yokohama Hospital
Division name Division of Cardiology and Cardiac Catheterization Laboratories
Zip code 224-8503
Address 35-1, Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL 045-949-7000
Homepage URL
Email alone_with_music@hotmail.com

Sponsor
Institute Showa University Northern Yokohama 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 the Institutional Review Board of Showa University Northern Yokohama Hospital
Address 35-1, Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa, Japan
Tel 045-949-7000
Email irb02syh@ofc.showa-u.ac.jp

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
2017 Year 12 Month 03 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 52
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
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 11 Month 26 Day
Anticipated trial start date
2017 Year 12 Month 02 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 03 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033660

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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