UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
Title of the study (Brief title)	Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
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 the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT), and to evaluate whether hemodynamic parameters affect plaque characteristics by using 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 concordance between cCTA minimal lumen area (MLA) and OCT MLA.
Key secondary outcomes	To evaluate the concordance between FFR value which derived cCTA and OCT. To evaluate the relation between coronary plaque characteristics and hemodynamic parameters by OCT and cCTA.

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	Hiromasa Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	Kenzo Uzu
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5846
Homepage URL
Email	kenzouduu@hotmail.com

Sponsor
Institute	Division of Cardiovascular Medicine Kobe University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025867