UMIN-CTR Clinical Trial
| 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 (Ver. 5) |
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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 |
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| Condition | ||
| Condition | Known or suspected coronary artery disease
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| Classification by specialty |
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| 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.
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| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1. Known or suspected coronary artery disease
2. Patients who were taken informed consent. |
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| 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. |
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| Target sample size | 60 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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 |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | coronary artery disease |
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| Participant flow | none |
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| Adverse events | none |
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| Outcome measures | Coronary flow reserve |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Cohort study |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011819 |
