UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019704
Receipt number R000021222
Scientific Title Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation Assessed by Continuous Glucose Monitoring and Optical Coherence Tomography
Date of disclosure of the study information 2015/11/10
Last modified on 2016/10/01 12:08:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation Assessed by Continuous Glucose Monitoring and Optical Coherence Tomography

Acronym

Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation

Scientific Title

Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation Assessed by Continuous Glucose Monitoring and Optical Coherence Tomography

Scientific Title:Acronym

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

1st name
Middle name
Last name Toshiro Shinke

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


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

1st name
Middle name
Last name Masaru Kuroda

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code


Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 6500017, JAPAN

TEL

078-382-5846

Homepage URL


Email

kuroro19800115@hotmail.com


Sponsor or person

Institute

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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 05 Month 15 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

(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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021222


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name