UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054279 |
|---|---|
| Receipt number | R000061913 |
| Scientific Title | Vascular function and advanced glycation end-products in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2024/04/28 |
| Last modified on | 2024/05/15 19:11:07 |
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Basic information
Public title
Vascular function and advanced glycation end-products in patients with acute myocardial infarction
Acronym
ANTI-AGE AMI
Scientific Title
Vascular function and advanced glycation end-products in patients with acute myocardial infarction
Scientific Title:Acronym
ANTI-AGE AMI
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To determine the association between Skin autofluorescence and temporal changes in cardiac, vascular, physical and renal function in patients with acute myocardial infarction.
2) The purpose of this study is to evaluate the correlation between conventional flow-mediated dilatation (conventional FMD) and vascular function indices assessed by ViewWave (Saraya Co., Ltd. Japan) and the correlation between the rate of temporal change of vascular function indices assessed by ViewWave and that of FMD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise tolerance (baseline values and changes over time from baseline values to month 3 and year 1)
Key secondary outcomes
･ Echocardiography, blood test, urinalysis, vascular function test (baseline values and changes over time from baseline values to month 3 and year 1)
･ Correlation between conventional FMD and plethysmography flow-mediated vasodilation (plethysmography FMD) measured by ViewWave(baseline values and the rate of changes over time from baseline values to month 3)
･ Intra- and inter-observer variability in conventional FMD and inter-measurement variability in plethysmography FMD measured by ViewWave.
･ Death, acute myocardial infarction, angina pectoris hospitalization, heart failure hospitalization, pneumonia, fracture, other events requiring hospitalization (arrhythmia, aortic disease, other) and their composite endpoints.
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
1) Patients undergoing inpatient care for acute myocardial infarction
2) Patients who underwent coronary angiography during hospitalization
3) Patients who are participating or scheduled to participate in cardiac rehabilitation
4) Patients who are 20 years of age or older at the time consent is obtained.
Key exclusion criteria
1) Patients within 30 days of open heart surgery
2) Patients on hemodialysis
3) Patients who are already scheduled to undergo open heart surgery within 1 year at the time of obtaining consent
4) Patients who are unable to give consent
5) Patients who are judged by a physician to be inappropriate to participate in the study.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miura |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular department, Division of Coronary Diseases
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, Japan
TEL
06-6170-1070
h_miura8217@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miura |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular department, Division of Coronary Diseases
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
TEL
06-6170-1070
Homepage URL
h_miura8217@yahoo.co.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology (Japan Society for the Promotion of Science)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saraya Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe Shinmachi, Suita, Osaka, Japan
Tel
06-6170-1070
h_miura8217@yahoo.co.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
国立循環器病研究センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
None
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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study
Method of recruitment of subjects: Patients who are hospitalized at the National Cerebral and Cardiovascular Center on or after the scheduled start date of enrollment and meet the selection and exclusion criteria will be asked to participate in the study.
Management information
Registered date
| 2024 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061913
