UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035021 |
|---|---|
| Receipt number | R000039934 |
| Scientific Title | Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease and with arteriosclerosis |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2021/05/30 14:44:31 |
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Basic information
Public title
Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease and with arteriosclerosis
Acronym
cereal food for anti-arteriosclerosis
Scientific Title
Effect of cereal breakfast on secondary prevention in the patients with ischemic heart disease and with arteriosclerosis
Scientific Title:Acronym
the benefit of cereal food for anti-arteriosclerosis
Region
| Japan |
Condition
Condition
Patients who underwent coronary artery bypass surgery due to ischemic heart disease or patients who have risk factor(s) for arteriosclerosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Secondary prevention for 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 after the surgery or patients who have risk factor(s) for arteriosclerosis
Key exclusion criteria
malignant tumor
GNRI<90
allergy for the food
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of cardiovascular surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of cardiovascular surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Calbee corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Midori-juji Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo-ku Tokyo Japan
Tel
03-3813-3111
saty-m@juntendo.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
順天堂医院（東京都）、緑十字クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2023 | 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
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039934
| Research Plan | |
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| 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 |
