UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039835 |
|---|---|
| Receipt number | R000043531 |
| Scientific Title | Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2022/03/24 20:45:36 |
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Basic information
Public title
Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability
Acronym
Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability
Scientific Title
Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability
Scientific Title:Acronym
Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between plaque rupture by optical coherence tomography (OCT) and intra-individual lipid variability including LDL-C and HDL-C.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
plaque rupture
Key secondary outcomes
Clinical course
Findings of optical coherence tomography
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Patients whose medical contents and prognostic information can be obtained from medical records
2, Patients who performed optical coherence tomography used percutaneous coronary intervention from January 1 2010 to June 30 2019
3, Patients whose LDL-C and HDL-C values were assessed at least three times during routine outpatient visits before the onset of ACS
4, No change in drugs that affect cholesterol, such as statins, during the observation period
5, The optical coherence tomography image in acute coronary syndrome patients has the quality that can be analyzed
Key exclusion criteria
1, Patients who expressed refusal of participation of this study
2, Patients who were performed coronary intervention during the observational period
3, Patients whose culprit lesion has been expanded with a balloon of 2.75 mm or more until the first optical coherence tomography scan,
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital
Division name
Cardiology
Zip code
6500017
Address
7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo
TEL
078-382-5111
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Nakano |
Organization
Kobe University Hospital
Division name
Cardiology
Zip code
650-0017
Address
7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo
TEL
078-382-5111
Homepage URL
dqswx303@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Cardiology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Cardiology
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
Kobe University Hospital
Address
7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo
Tel
078-382-6669
chiken@med.kobe-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
| 2020 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423612/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423612/
Number of participants that the trial has enrolled
296
Results
ACS patients were categorized into a plaque rupture ACS (PR-ACS) group (n=44) or a non-plaque rupture ACS (NPR-ACS) group. Patients with ACS had significantly higher LDL-C levels and cVIM in LDL-C than the control group. The PR-ACS group had significantly higher mean LDL-C levels and greater cVIM in LDL-C than the control group. The PR-ACS group had a significantly higher cVIM than the NPR-ACS group. Multivariate analysis revealed that higher cVIM of LDL-C was an independent predictor of PR-ACS.
Results date posted
| 2022 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 12 | Day |
Baseline Characteristics
patients with ACS whose cholesterol levels were assessed more three times during outpatient visits before the onset of ACS
Participant flow
This is a retrospective multicenter observational case control study and and information was collected from medical records.
Adverse events
not particular
Outcome measures
cVIM
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043531
