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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name