UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022404 |
|---|---|
| Receipt number | R000025819 |
| Scientific Title | Association between coronary microvascular dysfunction and glycemic variability |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2016/12/26 11:34:21 |
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Basic information
Public title
Association between coronary microvascular dysfunction and glycemic variability
Acronym
Association between coronary microvascular dysfunction and glycemic variability
Scientific Title
Association between coronary microvascular dysfunction and glycemic variability
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
tnishi@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nishi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
tnishi@chiba-u.jp
Sponsor or person
Institute
Chiba university Graduate School of Medicine
Institute
Department
Personal name
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)
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
| 2016 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025819
