UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043115
Receipt number R000046006
Scientific Title Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography
Date of disclosure of the study information 2021/01/24
Last modified on 2021/01/24 16:35:57

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography

Acronym

Coronary Plaque Characterization by NIRS: Association with CCTA

Scientific Title

Coronary Plaque Characterization by Near-infrared Spectroscopy for Identification of Plaque Vulnerability: Association with Coronary Computed Tomographic Angiography

Scientific Title:Acronym

Coronary Plaque Characterization by NIRS: Association with CCTA

Region

Japan


Condition

Condition

Ischemic Heart Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary lesions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between lipid core burden index (LCBI) as detected by NIRS-IVUS, and plaque characteristics by CCTA in coronary lesions.

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. At least 18 years of age
2. De novo, native coronary artery lesions
3. Blood cardiac biomarker (Troponin-T) levels less than the local laboratory the upper limit of normal (ULN) before PCI
4. Both NIRS and OCT catheters use are not contra-indicated
5. The lesion received one stent during the initial procedure

Key exclusion criteria

1. Prior coronary revascularization therapy (PCI and/or CABG) to target vessel
2. STEMI within the past 24 hours
3. Simultaneously treated with multi-vesssel PCI on initial procedure
4. LMT case
5. Chronic kidney disease (serum creatinine on admission more than 1.5 mg/dl)
6. Presented with hemodynamic instability (cardiogenic shock)
7. Complex lesion which need to do balloon dilatation (more than 2.0mm balloon or debulking device before pre-procedural NIRS-IVUS
8. Poor image quality case which the technician cannot perform either CTA or NIRS-IVUS measurements
9. Lesions with an EEM diameter <2.0mm

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Matsuo

Organization

Gifu Heart Center

Division name

Department of Cardiology

Zip code

500-8384

Address

4-14-4 Yabuta-minami, Gifu-city, Gifu

TEL

058-277-2277

Email

matsuo@heart-center.or.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Ota

Organization

Gifu Heart Center

Division name

Department of Cardiology

Zip code

500-8384

Address

4-14-4 Yabuta-minami, Gifu-city, Gifu

TEL

058-277-2277

Homepage URL


Email

ota@heart-center.or.jp


Sponsor or person

Institute

Gifu Heart Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board, Gifu Heart Center

Address

4-14-4 Yabuta-minami, Gifu-city, Gifu

Tel

058-277-2277

Email

ota@heart-center.or.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

2021 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016 Year 11 Month 01 Day

Date of IRB

2016 Year 11 Month 08 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

111


Management information

Registered date

2021 Year 01 Month 24 Day

Last modified on

2021 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name