UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010269 |
|---|---|
| Receipt number | R000011819 |
| Scientific Title | Assessment of coronary artery stenosis and vascular function and development of the effective treatment in patients with coronary artery disease |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2019/10/29 10:00:09 |
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Basic information
Public title
Assessment of coronary artery stenosis and vascular function and development of the effective treatment in patients with coronary artery disease
Acronym
Assessment of coronary artery stenosis and vascular function
Scientific Title
Assessment of coronary artery stenosis and vascular function and development of the effective treatment in patients with coronary artery disease
Scientific Title:Acronym
Assessment of coronary artery stenosis and vascular function
Region
| Japan |
Condition
Condition
Known or suspected coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study is to develop the comprehensive assessment of coronary artery disease by using the latest CT scan with low radiation exposure. Furthermore, we evaluate the effects of coronary risk factors such as hypertension, diabetes, and hyperlipidemia on the coronary artery disease.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of statins, angiotensin receptor blockers, and revascularization on coronary plaque and vascular function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronary stenosis
Plaque characteristics
Myocardial blood flow and coronary flow reserve
Key secondary outcomes
Subtraction of calcification
Myocardial flow imaging
Coronary blood flow speed
Shear stress of coronary artery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Known or suspected coronary artery disease
2. Patients who were taken informed consent.
Key exclusion criteria
1. Patients who were not taken informed consent.
2. Patients who have branchial asthma
3. Patients who have kidney disease (eGFR < 30ml/m2)
4. Patients who were not appropriate for this study judged by a doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Hokkaido University Graduate School of Medecine
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
Kita-ku Kita 15 Jyo Nishi 7 Chome
TEL
011-706-6973
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masanao |
| Middle name | |
| Last name | Naya |
Organization
Hokkaido University Graduate School of Medecine
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
Kita-ku Kita 15 Jyo Nishi 7 Chome
TEL
011-70-6973
Homepage URL
nayamasanao@yahoo.co.jp
Sponsor or person
Institute
Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Banyu Foundation Research Grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North 15, West 7
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
| 2013 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
10
Results
unpublished
Results date posted
| 2019 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
coronary artery disease
Participant flow
none
Adverse events
none
Outcome measures
Coronary flow reserve
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2013 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
