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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004390 |
Receipt No. | R000005241 |
Scientific Title | The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus |
Date of disclosure of the study information | 2010/11/01 |
Last modified on | 2015/04/27 |
Basic information | ||
Public title | The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus | |
Acronym | The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus | |
Scientific Title | The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus | |
Scientific Title:Acronym | The impact of dipeptidyl peptidase-4 inhibitor on coronary microvascular function in patients with type2 diabetes mellitus | |
Region |
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Condition | ||
Condition | Type 2 diabetic patients with stable angina pectoris who undergo percutaneous coronary intervention | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of dipeptidyl peptidase-4 inhibitor on microvascular function with intracoronary pressure/temperature sensor-tipped guide wire |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change in index of microcirculatory index |
Key secondary outcomes | Absolute and percent changes of high-sensitive CRP and adiponectine |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | DPP-4 inhibitor tretment 1 year after measurement of baseline IMR value | |
Interventions/Control_2 | no treatment | |
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) Stable angina pectoris
2) Type2 diabetes mellitus who are controlled well 3) Culprit lesion involving 75% or more of the stenosis without LAD 4) Successful revascularization of target lesion 5) Patients providing written consent for participattion in this clinical trial on their own volition after receiving a thorough explanation of the study |
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Key exclusion criteria | 1) Target lesion is left main coronary artery
2) Patients on hemodialysis 3) Patients with acute coronary syndorome 4) Patients with contraindication of antiplatelet or anticoagulation drug 5) Patients who are uncontrolled diabetes mellitus 6) Patients who are judged by the principal investigator to be ineligible for enrollment in the study |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hyogo College of Medicine | ||||||
Division name | Cardiovascular Division | ||||||
Zip code | |||||||
Address | 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN | ||||||
TEL | 0798-45-6553 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Hyogo College of Medicine | ||||||
Division name | Cardiovascular Division | ||||||
Zip code | |||||||
Address | 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN | ||||||
TEL | 0798-45-6553 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Cardiovascular Division, Hyogo College of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
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 | 兵庫医科大学病院(兵庫県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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/ctr_e/ctr_view.cgi?recptno=R000005241 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |