UMIN-CTR Clinical Trial

Public title

Low-density lipoprotein cholesterol associated with change in non-culprit plaque lipid burden of acute coronary syndrome

Acronym

Low-density lipoprotein cholesterol associated with change in non-culprit plaque lipid burden of acute coronary syndrome

Scientific Title

Low-density lipoprotein cholesterol associated with change in non-culprit plaque lipid burden of acute coronary syndrome

Scientific Title:Acronym

Low-density lipoprotein cholesterol associated with change in non-culprit plaque lipid burden of acute coronary syndrome

Region

Japan

Condition

acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will evaluate the changes in moderate stenosis lesions of non-culprit vessels one year later in ACS patients who reduced LDL-C to less than 55 mg/dL compared to those who reduced it to between 55 and 70 mg/dL using near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) to determine whether further lowering LDL-C is beneficial.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

In ACS patients who reduced LDL-C to less than 55 mg/dL compared to those who reduced it to between 55 and 70 mg/dL, we will evaluate how the plaques with maxLCBI4mm > 400 and < 400 in non-culprit lesions changed as assessed by NIRS-IVUS. Additionally, we will examine whether there are any changes in lipid markers other than LDL-C in these patients.

Key secondary outcomes

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

90

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) patients were admitted with ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris); (2) intermediate stenosis in non-culprit lesions on coronary angiography or CCTA; and (3) NIRS-IVUS evaluation for intermediate stenosis after percutaneous coronary intervention.

Key exclusion criteria

(1) chronic kidney disease as shown by an estimated glomerular filtration rate <30 ml/min/1.73 m2; (2) presentation with hemodynamic instability; (3) severe valvular heart diseases, (4) left main trunk lesions; (5) lesions that could not be evaluated by NIRS-IVUS for any reason (e.g., tortuous vessels, severe stenosis, and calcification that made catheter passage difficult); and (6) poor image quality that resulted in an inability to perform CCTA or NIRS-IVUS analysis.

Target sample size

100

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Ueno

Organization

Kindai University Faculty of Medicine

Division name

Division of Cardiology

Zip code

589-8511

Address

377-2, Ohno-Higashi, Osakasayama, Osaka, Japan

TEL

81-72-366-0221

Email

mueno@med.kindai.ac.jp

Name of contact person

1st name	Kazuyoshi
Middle name
Last name	Kakekhi

Organization

Kindai University Faculty of Medicine

Division name

Division of Cardiology

Zip code

589-8511

Address

377-2, Ohno-Higashi, Osakasayama, Osaka, Japan

TEL

81-72-366-0221

Homepage URL

Email

kakehi324@yahoo.co.jp

Institute

Kindai University Faculty of Medicine

Institute

Department

Personal name

Organization

Kindai University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kindai University Faculty of Medicine

Address

377-2, Ohno-Higashi, Osakasayama, Osaka, Japan

Tel

81-72-366-0221

Email

kakehi324@yahoo.co.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

2024

Year

09

Month

30

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

2021

Year

10

Month

01

Day

Date of IRB

2021

Year

11

Month

18

Day

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

After the protocol has been approved by the Director, case enrollment will begin until December 2025 (the period of accumulation may be changed depending on the status of case enrollment). The study period, including the follow-up period, will be until the end of December 2026.

Registered date

2024

Year

09

Month

22

Day

Last modified on

2024

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063523

Single case data URL

Value
https://center6.umin.ac.jp/ice/63523