UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050061 |
|---|---|
| Receipt number | R000057031 |
| Scientific Title | Lifestyle survey of patients with acute myocardial infarction |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2023/07/19 15:04:17 |
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Basic information
Public title
Lifestyle survey of patients with acute myocardial infarction
Acronym
Lifestyle survey of patients with acute myocardial infarction
Scientific Title
Lifestyle survey of patients with acute myocardial infarction
Scientific Title:Acronym
Lifestyle survey of patients with acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the actual conditions of living habits such as family environment, dietary preferences, eating habits, exercise habits, and smoking for the purpose of reflecting on the implementation of effective comprehensive diet therapy in the future.In addition, the lifestyle habits leading to the onset were examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Favorite foods by age group.
Key secondary outcomes
SEX, BMI, blood pressure, high-density lipoprotein cholesterol (HDL-Cho), low-density lipoprotein cholesterol (LDL-Cho), neutral lipid, creatinine, alcohol intake, the number of cigarettes, presence or absence of diabetes, family environment, favorite foods (preferred food), snacks (presence or absence frequency content), drinking (presence or absence frequency content), smoking (presence or absence smoking history amount), eating out (presence or absence frequency content), exercise habits (presence or absence frequency content) by age group.
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
Patients diagnosed with acute myocardial infarction over the age of 20.
Key exclusion criteria
Patients with missing data (favorite foods).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Matsuzaki |
Organization
Fukuoka University Nishijin Hospital
Division name
Department of Nutrition
Zip code
814-8522
Address
15-7 Sohara, Sawara, Fukuoka-City, Fukuoka
TEL
092-831-1211
eiyoukeiko@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Matsuzaki |
Organization
Fukuoka University Nishijin Hospital
Division name
Department of Nutrition
Zip code
814-8522
Address
15-7 Sohara, Sawara, Fukuoka-City, Fukuoka
TEL
092-831-1211
Homepage URL
eiyoukeiko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Keiko Matsuzaki
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Fukuoka University
Address
8-19-1 Nanakuma, Jonan, Fukuoka City, Fukuoka.
Tel
092-871-6631
fupr@adm.fukuoka-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
| 2023 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
117
Results
About 80% have a snacking habit and about 60% have a habit of eating out, and these adjustment guidance is necessary. The average BMI was 25.7(3.3)kg/m2, and there were obesity, hypertension, dyslipidemia, and about 40% had diabetes. In terms of preference, they prefer foods high in fat the most, and guidance on the adjustment of foods such as meat and oil is essential.
Results date posted
| 2023 | Year | 07 | Month | 19 | Day |
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
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Informed consent was obtained from all patients via consent confirm. The investigation conforms to the principles outlined in the Declaration of Helsinki. The present study was approved by the ethics committee of Fukuoka University (approval number: N21-11-001) and was performed form April 2014 to January 2020 (cross-sectional study).
Management information
Registered date
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057031
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