UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008238 |
|---|---|
| Receipt number | R000009713 |
| Scientific Title | Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2016/08/19 17:56:08 |
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Basic information
Public title
Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging
Acronym
Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging
Scientific Title
Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging
Scientific Title:Acronym
Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging
Region
| Japan |
Condition
Condition
Diabetic patients with old myocardial infarction or angina pectoris
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether alogriptin improves coronary flow reserve by MRI in diabetic patients with old myocardial infarction or angina pectoris
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronary flow reserve evaluated by MRI
Key secondary outcomes
high-sensitivity CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alogliptin group
Interventions/Control_2
control group
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with old myocardial infarction or angina pectoris
Key exclusion criteria
1. Type 1 diabetes mellitus
2. Patient who already takes DPP4 inhibitors
3. Severe renal dysfunction (eGFR<30mL/min/1.73m2)
4. General contraindication to MRI (Claustrophobia, after pacemaker implantation etc.)
5. Patients who cannot hold breathe for about 10 seconds due to dyspnea
6. Contraindication to adenosine triphosphate infusion (asthma, advanced atrioventricular block etc.)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Division of Cardiology
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Division of Cardiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
Management information
Registered date
| 2012 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009713
