UMIN-ICDS Clinical Trial

Public title

Study of the Association Between Clonal Hematopoiesis (CHIP) and Coronary Plaque Characteristics

Acronym

CHIP-PLAQUE Study

Scientific Title

Comprehensive CT Analysis of Coronary Plaques in Patients With Clonal Hematopoiesis

Scientific Title:Acronym

CHIP-PLAQUE Study

Region

Japan

Condition

Atherosclerotic Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The aim of this study is to evaluate the impact of clonal hematopoiesis of indeterminate potential (CHIP) on coronary plaque phenotype using comprehensive coronary CT analysis.

Basic objectives2

Others

Basic objectives -Others

To evaluate the impact of CHIP on coronary plaque volume and burden, plaque characteristics (including plaque composition and high-risk features), and coronary inflammation. In addition, the associations of CHIP with major cardiovascular events, variant allele fraction (VAF), and individual gene mutations and their relationships with coronary CT findings will be investigated.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Total coronary plaque volume and plaque burden assessed by coronary computed tomography angiography (CCTA)

Key secondary outcomes

Coronary plaque characteristics (plaque composition and high-risk plaque features), pericoronary adipose tissue attenuation (PCAT attenuation), major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, and coronary revascularization), the association between variant allele fraction (VAF) and coronary CT findings, and the association between individual gene mutations and coronary CT findings.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent coronary computed tomography (CT) and subsequently underwent coronary angiography within 6 months of the CT scan.

Patients who participate in the study led by the National Cerebral and Cardiovascular Center on the clinical significance of somatic mosaicism, and for whom genetic analyses including CHIP are performed using blood samples collected at the time of coronary angiography.

Patients aged 18 years or older at the time of obtaining informed consent.

Patients who are able to understand the study procedures and provide written informed consent.

Key exclusion criteria

Patients with a history of hematologic malignancy.

Patients with a history of bone marrow transplantation.

Patients who have received radiotherapy, chemotherapy, or immunotherapy for solid tumors within the past two years (patients treated with local surgery alone are not excluded).

Patients deemed inappropriate for inclusion in the study at the discretion of the principal investigator.

Target sample size

600

Name of lead principal investigator

1st name	Hiromasa
Middle name
Last name	Otake

Organization

Kobe University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

TEL

078-382-5111

Email

hotake@med.kobe-u.ac.jp

Name of contact person

1st name	Daichi
Middle name
Last name	Fujimoto

Organization

Kobe University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

TEL

078-382-5111

Homepage URL

Email

daichifujimoto88123@gmail.com

Institute

Kobe University Hospital

Institute

Department

Personal name

Organization

Kobe University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Ethics Committee of Kobe University Graduate School of Medicine

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan

Tel

0783826669

Email

chiken@med.kobe-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

2026

Year

06

Month

24

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

2026

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

06

Month

24

Day

Last follow-up date

2031

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective observational cohort study. Patients with coronary artery disease who undergo coronary CT and genetic analysis will be enrolled. Associations between CHIP status and coronary plaque burden, plaque characteristics, coronary inflammation, and clinical outcomes will be evaluated. No study-specific intervention will be performed.

Registered date

2026

Year

06

Month

23

Day

Last modified on

2026

Year

06

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070984