UMIN-CTR Clinical Trial

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
Institute	Kobe University Hospital Cardiology
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043531