UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation Assessed by Continuous Glucose Monitoring and Optical Coherence Tomography
Title of the study (Brief title)	Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation
Region	Japan

Condition
Condition	stable angina pectoris
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the effect of glucose fluctuation on vessel healing nine months after everolimus eluting stent deployment, and to assess the impact of glucose fluctuation on clinical outcomes in patients with coronary artery disease
Basic objectives2	Others
Basic objectives -Others	Pathophysiology
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between glucose variability and neointimal proliferation nine (six to twelve) months after stenting assessed continuous glucose monitoring (CGM) and coronary imaging device (optical coherence tomography; OCT)
Key secondary outcomes	Major cardiovascular adverse events (target lesion revascularization, myocardial infarction and cardiac death) at nine (six to twelve) months after percutaneous coronary intervention.

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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)patients whose glucose fluctuation was assessed by continuous glucose monitoring before percutaneous coronary intervention (PCI) 2)patients treated with everolimus-eluting stent at PCI 3)LDL-chol < 100mg/dl in patients without statin. LDL-chol < 120mg/dl in patients with statin. 4)patients between 20 and 80 years old 5)written consent for participation in the study
Key exclusion criteria	Patients meeting one of the following conditions will be excluded: 1) treated with other kind of stent 2) unsuitable anatomy for OCT analysis in stented segment 3) severe renal dysfunction 4) any change of medical interventions for the control of diabetes, lipids, and hypertension during this study 5) judged as ineligible by clinical investigators
Target sample size	70

Research contact person
Name of lead principal investigator	Toshiro Shinke
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	078-382-5111
Email	shinke@med.kobe-u.ac.jp

Public contact
Name of contact person	Masaru Kuroda
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN
TEL	078-382-5846
Homepage URL
Email	kuroro19800115@hotmail.com

Sponsor
Institute	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
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	2015 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 15 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	(A)study design A prospective observational study(case-control study) (B)subject consecutive patients who fulfilled with the inclusion criteria from June 2012 to May 2014 in our institution (C)study protcol 1. On admission of the index procedure, a blood sample analysis is performed under fasting conditions to evaluate levels of creatinine, glycosylated hemoglobin (HbA1c), total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, and C-reactive protein. In addition, a 75-g OGTT is performed in all patients, and levels of plasma glucose and immunoreactive insulin are evaluated just before and 120 min after the oral glucose load. Subcutaneous interstitial glucose levels are monitored over a period of 3 consecutive days using the CGM System iPro2 (Medtronic, Northridge, CA). 2. After the CGM examination, all patients undergo catheterization procedure for PCI to native coronary arteries guided by intravascular ultrasound (IVUS) (Eagle Eye Platinum 3.5F 20-MHz; Volcano Corp, Rancho Cordova, CA, USA) and are planned to be treated with everolimus-eluting stent implantation. The IVUS procedure is planned to be performed in a standard fashion, using automated motorized 0.5 mm/s pullback. 3. 9 months after the index stent procedure, we intend to perform follow-up CAG and OCT examination for stented segment, and evaluate the incidence of major adverse cardiovascular events.

Management information
Registered date	2015 Year 11 Month 09 Day
Last modified on	2016 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021222