UMIN-CTR Clinical Trial

Public title

Association between HDL functionality and coronary plaque
in patients with stable angina and acute coronary syndrome

Acronym

Association between HDL functionality and coronary plaque

Scientific Title

Association between HDL functionality and coronary plaque
in patients with stable angina and acute coronary syndrome

Scientific Title:Acronym

Association between HDL functionality and coronary plaque

Region

Japan

Condition

Coronary artery disease

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Elucidate the association between HDL functionality and coronary plaque
in patients with stable angina and acute coronary syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Elucidate the association between HDL functionality and late loss, %Diameter stenosis, Minimum Lumen Diameter, Loss Index assessed with QCA. (Comparison among the groups and between baseline (0 month) and 6-12 month.)

Key secondary outcomes

1)Changes in characteristics of coronary plaque using IVUS (IB-IVUS, VH-IVUS).
2)Changes in characteristics of coronary plaque using OCT.
3)Association between serum lipids and coronary plaque.
4)Association between inflammatory markers and coronary plaque.
5)Difference of HDL functionality between healthy volunteer and CAD patients.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who need coronary angiography.
Patient who agreed with document.

Key exclusion criteria

1) hepatic failure
2) malignancy
3) active systemic inflammatory disease, before and after the operation, severe trauma
4) pregnant, lactating, or planned or possible pregnant
5) cardiogenic shock
6) ineligible for any other reasons

Target sample size

500

Name of lead principal investigator

1st name	Shin-ichiro
Middle name
Last name	Miura

Organization

Fukuoka University School of Medicine

Division name

Division of Cardiology

Zip code

814-0180

Address

7-45-1, Nanakuma, Jyounan-ku, Fukuoka-city, Fukuoka 814-0180, Japan

TEL

092-801-1011

Email

saku-k@fukuoka-u.ac.jp

Name of contact person

1st name	Shin-ichiro
Middle name
Last name	Miura

Organization

Fukuoka University School of Medicine

Division name

Division of Cardiology

Zip code

814-0180

Address

7-45-1, Nanakuma, Jyounan-ku, Fukuoka-city, Fukuoka 814-0180, Japan

TEL

092-801-1011

Homepage URL

Email

simaizumi@fukuoka-u.ac.jp

Institute

Division of Cardiology, Fukuoka University School of Medicine

Institute

Department

Personal name

Organization

KAKENHI Grant Number 24790789 of the Japan Society for the Promotion of Science (JSPS).

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University - Medical Ethics Review Board

Address

7-45-1, Nanakuma, Jyounan-ku, Fukuoka-city, Fukuoka 814-0180, Japan

Tel

092-801-1011

Email

fumed-ethics@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

10

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

After the acquisition of blood samples we will measure the HDL function of baseline (0 month) sample, and divide the patients to 4 groups.
1. Elucidate the association between HDL functionality and QCA data. (Comparison between baseline and follow up (6-12 month).)
2. Elucidate the association between HDL functionality and plaque characteristics assessed with IVUS/OCT/QCA. (Comparison among the groups at baseline.)
3. If we perform the IVUS or OCT at follow up (6-12 month), elucidate the association between HDL functionality and plaque characteristics (Comparison among the groups and between baseline and follow up. )
4. Compare the HDL functionality of healthy volunteer with HDL functionality of CAD patients.

Registered date

2013

Year

12

Month

02

Day

Last modified on

2023

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014591