UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between coronary microvascular dysfunction and glycemic variability
Title of the study (Brief title)	Association between coronary microvascular dysfunction and glycemic variability
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between coronary microvascular dysfunction and daily glycemic variability.
Basic objectives2	Others
Basic objectives -Others	Coronary physiological assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the index of microcirculatory resistance (IMR) between high MAGE (mean amplitude of glycemic excursions) and low MAGE patients. MAGE is measured by a continuous glucose monitoring system (CGMS).
Key secondary outcomes	Evaluating the relationship between coronary physiological measurements (IMR, coronary flow reserve [CFR], and fractional flow reserve [FFR]) and CGMS findings (mean glucose level, standard deviation of glucose levels, MAGE and hypoglycemia duration). Evaluating the relationship between coronary physiological measurements (IMR, CFR and FFR) and HbA1c, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride, body mass index, smoking status, renal function, hs-CRP, hs-troponin T and RHI. Comparison of coronary physiological measurements (IMR, CFR and FFR) between three groups: diabetes mellitus, impaired glucose tolerance and normal glucose tolerance.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Assessing the coronary microvascular function using a Certus Pressure Wire.
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	Patients with coronary artery disease who are undergoing coronary angiography 20 years of age or older Patients who have signed consent forms
Key exclusion criteria	Patients who are on diabetes medication Acute coronary syndrome Significant coronary stenosis in the left anterior descending artery (LAD) Prior myocardial infarction in the LAD territory Severe skin disease Severe blood disorder
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshio Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	tnishi@chiba-u.jp

Public contact
Name of contact person	Takeshi Nishi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	tnishi@chiba-u.jp

Sponsor
Institute	Chiba university Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 10 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 22 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025819