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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035021
Receipt No. R000039934
Official scientific title of the study Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/27

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Basic information
Official scientific title of the study Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease
Title of the study (Brief title) cereal breakfast for secondary prevention
Region
Japan

Condition
Condition Patients who underwent coronary artery bypass surgery due to ischemic heart disease
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Secondary prevention of ischemic heart disease due to antihypertensive effect or improve of dyslipidemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take 50 gram of cereal breakfast for breakfast
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 patients with stable condition more than 3 months after the surgery
Key exclusion criteria malignant tumor
GNRI<90
allergy for the food
Target sample size 100

Research contact person
Name of lead principal investigator Satoshi Matsushita
Organization Juntendo University
Division name Department of cardiovascular surgery
Address 2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email saty-m@juntendo.ac.jp

Public contact
Name of contact person Satoshi Matsushita
Organization Juntendo University
Division name Department of cardiovascular surgery
Address 2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email saty-m@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Calbee corporation
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Anticipated trial start date
2018 Year 12 Month 03 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039934

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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