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 |
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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
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
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
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
