UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039835
Receipt number R000043531
Scientific Title Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability
Date of disclosure of the study information 2020/03/24
Last modified on 2022/03/24 20:45:36

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Basic information

Public title

Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability

Acronym

Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability

Scientific Title

Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability

Scientific Title:Acronym

Observational study to evaluate the relationship between lesion characteristics by optical coherence tomography in ACS patients and intra-individual lipid variability

Region

Japan


Condition

Condition

acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the relationship between plaque rupture by optical coherence tomography (OCT) and intra-individual lipid variability including LDL-C and HDL-C.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

plaque rupture

Key secondary outcomes

Clinical course
Findings of optical coherence tomography


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

1, Patients whose medical contents and prognostic information can be obtained from medical records
2, Patients who performed optical coherence tomography used percutaneous coronary intervention from January 1 2010 to June 30 2019
3, Patients whose LDL-C and HDL-C values were assessed at least three times during routine outpatient visits before the onset of ACS
4, No change in drugs that affect cholesterol, such as statins, during the observation period
5, The optical coherence tomography image in acute coronary syndrome patients has the quality that can be analyzed

Key exclusion criteria

1, Patients who expressed refusal of participation of this study
2, Patients who were performed coronary intervention during the observational period
3, Patients whose culprit lesion has been expanded with a balloon of 2.75 mm or more until the first optical coherence tomography scan,

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Hiromasa
Middle name
Last name Otake

Organization

Kobe University Hospital

Division name

Cardiology

Zip code

6500017

Address

7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo

TEL

078-382-5111

Email

hotake@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Shinsuke
Middle name
Last name Nakano

Organization

Kobe University Hospital

Division name

Cardiology

Zip code

650-0017

Address

7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo

TEL

078-382-5111

Homepage URL


Email

dqswx303@yahoo.co.jp


Sponsor or person

Institute

Kobe University Hospital
Cardiology

Institute

Department

Personal name



Funding Source

Organization

Kobe University Hospital
Cardiology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University Hospital

Address

7-5-2 Kusunokimachi, Tyuo-ku, Kobe, Hyogo

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



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 24 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423612/

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423612/

Number of participants that the trial has enrolled

296

Results

ACS patients were categorized into a plaque rupture ACS (PR-ACS) group (n=44) or a non-plaque rupture ACS (NPR-ACS) group. Patients with ACS had significantly higher LDL-C levels and cVIM in LDL-C than the control group. The PR-ACS group had significantly higher mean LDL-C levels and greater cVIM in LDL-C than the control group. The PR-ACS group had a significantly higher cVIM than the NPR-ACS group. Multivariate analysis revealed that higher cVIM of LDL-C was an independent predictor of PR-ACS.

Results date posted

2022 Year 03 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 12 Day

Baseline Characteristics

patients with ACS whose cholesterol levels were assessed more three times during outpatient visits before the onset of ACS

Participant flow

This is a retrospective multicenter observational case control study and and information was collected from medical records.

Adverse events

not particular

Outcome measures

cVIM

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 13 Day

Date of IRB

2019 Year 09 Month 13 Day

Anticipated trial start date

2019 Year 09 Month 13 Day

Last follow-up date

2019 Year 09 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

not particular


Management information

Registered date

2020 Year 03 Month 16 Day

Last modified on

2022 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043531


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name