UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of alogliptin on coronary flow reserve evaluated by magnetic resonance imaging
Title of the study (Brief title)	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	Shingo Kato
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Division of Cardiology
Address	6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL
Email

Public contact
Name of contact person	Shingo Kato
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Division of Cardiology
Address
TEL
Homepage URL
Email

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009713