UMIN-ICDS Clinical Trial

Public title

Patient characteristics promoting lipidic coronary plaque

Acronym

Patient characteristics promoting lipidic coronary plaque

Scientific Title

Exploring Risk Factors Promoting Lipidic coronary plaque formation

Scientific Title:Acronym

Risk Factors Promoting Lipidic coronary plaque formation

Region

Japan

Condition

Coronary Artery Disease

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Lipid components in coronary artery plaques have been shown to be strongly involved in the progression of coronary atherosclerosis. Recently, it has been possible to identify lipid plaques in vivo using near-infrared spectroscopy (NIRS). However, patient factors involved in lipid plaques identified by NIRS are not clear. The aim of study is to identify risk factors promoting lipidic coronary plaques.

Basic objectives2

Others

Basic objectives -Others

Predictive factor

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Impact of blood inframmatroy markers (IL-1, IL-18 and TNF-alpha) on vulnerability of coronary culprit lesion(max lipid core burden index)

Key secondary outcomes

1. Impact of conventional coronary risk factors (hypertension, diabetes, dyslipidemia, smoking history, body mass index and famaily history) on vulnerability of coronary culprit and non-culprit lesion
2. Impact of blood inframmatroy markers (IL-1, IL-18 and TNF-alpha) on vulnerability of coronary non-culprit lesion(max lipid core burden index)
3. Exploring predictive model using plaque charcterization and patient characteristics

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

1. Patients who scheduled percutaneous coronary intervention (PCI) due to coronary artery disease
2. NIRS-IVUS is planned to use as an intravascular imaging device during PCI

Key exclusion criteria

Patients considered not eligible for the study by the attending doctor due to other reasons

Target sample size

1000

Name of lead principal investigator

1st name	Shin-ichiro
Middle name
Last name	Miura

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code

814-0180

Address

7-45-1, Nanakuma, Jonanku, Fukuoka, Japan

TEL

092-801-1011

Email

miuras@cis.fukuoka-u.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Kuwano

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code

810-0014

Address

7-45-1, Nanakuma, Jonanku, Fukuoka, Japan

TEL

092-801-1011

Homepage URL

Email

tkuwano@fukuoka-u.ac.jp

Institute

Fukuoka University

Institute

Department

Personal name

Organization

Fukuoka University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University - Medical Ethics Review Board

Address

7-45-1, Nanakuma, Jonanku, Fukuoka, 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

福岡大学病院

Date of disclosure of the study information

2023

Year

04

Month

19

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

Preinitiation

Date of protocol fixation

2023

Year

04

Month

10

Day

Date of IRB

Anticipated trial start date

2023

Year

04

Month

20

Day

Last follow-up date

2033

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Coronary plaque characteristics will be evaluated using NIRS-IVUS at culprit lesion pre- and post PCI. Vessel imaging for non-culprit lesion will be performed after the completion of PCI for culprit lesion. The obtained coronary plaque images will be characterized using an analysis workstation (CAAS intravascular, Pie Medical imaging.), including quantification of lipids in the plaque. The results will be prospectively observed in relation to patient factors, including laboratory values. 10 ml of blood will be drawn from the blood access (sheath introducer) during PCI for specific blood tests. Blood concentraton of IL-1, IL-18, TNF-alpha and PAI-1 will be measured by ELIZA method. During the study period (planned to be 5 years after participation), patients will be followed up by outpatient visits or by telephone or letter (timing of the study will be at the time of enrollment and 1, 2, 3, 4, and 5 years later).

Registered date

2023

Year

04

Month

11

Day

Last modified on

2023

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057903