UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to assess the association with serum zinc and the severity of myocardial infarction and prognosis
Title of the study (Brief title)	Zinc in patients with myocardial infarction
Region	Japan

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

Objectives
Narrative objectives1	To assess the association serum zinc and severity of MI, and short~mid term prognosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital death, cardiovascular death, readmission due to cardiovascular events, all cause death.
Key secondary outcomes	Laboratory data including BNP, CK, CK-MB, creatinine, eGFR, liver function. echocardiography, NYHA class

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Acute myocardial infarction Male or female subjects over 20 years of age at the time of informed consent Ability to provide written informed consent
Key exclusion criteria	Patients with liver cirrhosis, dialysis, inflammatory bowel disease, pancreatitis, systemic inflammatory disease, or sickle cell disease. Patients had a history of pancreatectomy or small intestinal resection. Patients who are judged to be inappropriate to this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Toshitaka Okabe
Organization	Showa University Northern Yokohama Hospital
Division name	Division of Cardiology and Cardiac Catheterization Labs
Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL	045-949-7000
Email	alone_with_music@hotmail.com

Public contact
Name of contact person	Toshitaka Okabe
Organization	Showa University Northern Yokohama Hospital
Division name	Division of cardiology and Cardiac Cathteriation Labs
Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokomaha, Kanagawa
TEL	045-949-7000
Homepage URL
Email	alone_with_music@hotmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital Division of Cardiology and Cardiac Catheterization Labs
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)

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	2015 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 28 Day
Anticipated trial start date	2015 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	A prospective study

Management information
Registered date	2015 Year 08 Month 28 Day
Last modified on	2019 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021796