UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034324 |
|---|---|
| Receipt number | R000034451 |
| Scientific Title | Association of coronary plaque morphology with impairment of cholesterol uptake capacity (CUC), a novel indicator for high-density lipoprotein (HDL) functionality: OCT-based Observation Study |
| Date of disclosure of the study information | 2018/09/29 |
| Last modified on | 2021/03/31 15:03:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association of coronary plaque morphology with impairment of cholesterol uptake capacity (CUC), a novel indicator for high-density lipoprotein (HDL) functionality: OCT-based Observation Study
Acronym
Association of coronary plaque morphology with cholesterol uptake capacity (CUC), a novel indicator for HDL functionality
Scientific Title
Association of coronary plaque morphology with impairment of cholesterol uptake capacity (CUC), a novel indicator for high-density lipoprotein (HDL) functionality: OCT-based Observation Study
Scientific Title:Acronym
Association of coronary plaque morphology with cholesterol uptake capacity (CUC), a novel indicator for HDL functionality
Region
| Japan |
Condition
Condition
Patients with dyslipidemia and with or suspected of having coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to clarify the cross-sectional relationship between CUC and coronary plaque morphology, assessed by optical coherence tomography (OCT), and to investigate the relationship between impaired CUC and the progression of coronary atherosclerosis.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Coronary plaque characteristics assessed by the optical coherence tomography (OCT).
2.Association between coronary plaque morphology assessed by OCT and cholesterol uptake capacity.
Key secondary outcomes
Association between coronary plaque characteristics assessed by the intravascular ultrasound(IVUS) or coronary angiography and cholesterol uptake capacity.
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
Retrospective observational study.
Patients who was undergone coronary angiography and measured CUC after January 2010 in Kobe university hospital.
Key exclusion criteria
1) anatomically unsuitable target artery for OCT
2) patients who have had heart failure (NYHA >III)
3) renal insufficiency with baseline creatinine level > 2.0 mg/dL except for those under hemodialysis
4) who had a history of cancer in the previous 5 years
5) who were under inflammatory conditions such as active infections, inflammatory arthritis, or connective tissue disease.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Toh |
Organization
Kobe university graduate school of medicine
Division name
Evidence-based laboratory medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017
TEL
078-382-5846
rtoh@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Toh |
Organization
Kobe university graduate school of medicine
Division name
Evidence-based laboratory medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017
TEL
078-382-5846
Homepage URL
rtoh@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university hospital department of cardiovascular medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe university hospital department of cardiovascular medicine
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
Kobe university hospital clinical and translational research center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017
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
神戸大学医学部付属病院/ Kobe university hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 29 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospecive observational study
We examine the relationship between the change in CUC and the risk of cardiovascular disease and factors influencing CUC.
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034451
