UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010269
Receipt No. 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

* 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 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
Email 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
Email nayamasanao@yahoo.co.jp

Sponsor
Institute Cardiovascular Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011819

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.