UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059557 |
|---|---|
| Receipt number | R000068121 |
| Scientific Title | Prospective observational study to assess changes in lipid profiles during the acute phase of acute myocardial infarction: Fluctuation -LIPID AMI study. |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2025/10/27 20:22:14 |
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Basic information
Public title
Prospective observational study to assess changes in lipid profiles during the acute phase of acute myocardial infarction: Fluctuation -LIPID AMI study.
Acronym
Fluctuation-LIPID AMI study
Scientific Title
Prospective observational study to assess changes in lipid profiles during the acute phase of acute myocardial infarction: Fluctuation -LIPID AMI study.
Scientific Title:Acronym
Fluctuation-LIPID AMI study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in lipid profiles during the acute phase in patients who underwent PCI for acute myocardial infarction, and to determine which background factors influence these changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lipid profiles during the acute phase of acute myocardial infarction.
Key secondary outcomes
Analysis of background factors affecting changes in lipid profiles (peak CK, time from onset to visit, presence or absence of prior lipid-lowering therapy, etc).
Changes in Lp(a) levels before PCI, after PCI, at 1 week, and at 3 months.
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 who underwent percutaneous coronary intervention for acute coronary syndrome.
Key exclusion criteria
Patients who are under 20 years old.
Patients judged by the principal investigator to be inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Oyama |
Organization
Ina Central Hospital
Division name
Cardiovascular Medicine
Zip code
3968555
Address
1313-1 Koshiroukubo, Ina, Nagano, 396-8555, Japan.
TEL
0265-72-3121
yushioyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Oyama |
Organization
Ina Central Hospital
Division name
Cardiovascular Medicine
Zip code
3968555
Address
1313-1 Koshiroukubo, Ina, Nagano, 396-8555, Japan.
TEL
0265-72-3121
Homepage URL
yushioyama@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Ina Central Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
The ethics committee of Ina Central Hospital
Address
1313-1 Koshiroukubo, Ina, Nagano, 396-8555, Japan.
Tel
0265-72-3121
ht26727@inahp.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
| 2025 | Year | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aimed to investigate the changes in lipid profiles during the acute phase of acute myocardial infarction in Japanese patients and to determine which background factors influence these changes.
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068121
