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 |
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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
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
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
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
