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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025612
Receipt No. R000025867
Scientific Title Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
Date of disclosure of the study information 2017/01/11
Last modified on 2017/01/11

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Basic information
Public title Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
Acronym Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
Scientific Title Comparisons of morphological measurement and intracoronary hemodynamic parameters between coronary computed tomography and optical coherence tomography
Scientific Title:Acronym 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
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
Email hotake@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenzo Uzu
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 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)

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 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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