UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025611
Receipt number R000025825
Scientific Title Impact of intracoronary hemodynamic forces on serial changes of coronary plaque
Date of disclosure of the study information 2017/01/11
Last modified on 2017/01/11 09:04:39

* 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

Impact of intracoronary hemodynamic forces on serial changes of coronary plaque

Acronym

Impact of intracoronary hemodynamic forces on serial changes of coronary plaque

Scientific Title

Impact of intracoronary hemodynamic forces on serial changes of coronary plaque

Scientific Title:Acronym

Impact of intracoronary hemodynamic forces on serial changes of coronary plaque

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate whether hemodynamic parameters affect plaque initiation or progression by coronary computed tomography angiography(cCTA) and optical coherence tomography (OCT).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the relation between coronary plaque characteristics and hemodynamic parameters by OCT and cCTA.

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

Key exclusion criteria

1. Prior coronary artery bypass graft (CABG) surgery
2. Contraindication to beta blocker agents or nitrates
3. Tachycardia or significant arrhythmia
4. Impaired chronic renal function (eGFR <30)
5. Subjects with known anaphylactic allergy to iodinated contrast material
6. Pregnancy or unknown pregnancy status in subject of childbearing potential
7. Cases with poor OCT or CCTA image for analyzing

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Bon-Kwon KOO

Organization

Seoul National University College of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


Address

101 Daehang-ro, Chongno-gu, Seoul, 110-744, Korea

TEL

+82-2-2072-2062

Email

bkkoo@snu.ac.kr


Public contact

Name of contact person

1st name
Middle name
Last name Hiromasa Otake

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5846

Homepage URL


Email

hotake@med.kobe-u.ac.jp


Sponsor or person

Institute

Seoul National University College of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Akashi medical center

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 01 Month 11 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

Open public recruiting

Date of protocol fixation

2008 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective and retrospective, multicenter study


Management information

Registered date

2017 Year 01 Month 11 Day

Last modified on

2017 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name