UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014061 |
|---|---|
| Receipt number | R000016372 |
| Scientific Title | Impact of glycemic variability on ischemia reperfusion injury in ST-elevation myocardial infarction |
| Date of disclosure of the study information | 2014/05/26 |
| Last modified on | 2014/12/02 14:19:07 |
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Basic information
Public title
Impact of glycemic variability on ischemia reperfusion injury in ST-elevation myocardial infarction
Acronym
glycemic variability and reperfusion injury
Scientific Title
Impact of glycemic variability on ischemia reperfusion injury in ST-elevation myocardial infarction
Scientific Title:Acronym
glycemic variability and reperfusion injury
Region
| Japan |
Condition
Condition
ST-segment elevation myocardial infarction (STEMI) treated with primary PCI
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to elucidate the impact of glycemic variability derived from continuous glucose monitoring system (CGMS) on ischemia reperfusion after primary PCI in patient with STEMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the relationship between the mean amplitude of glycemic excursions (MAGE) and the following surrogate endpoints of ischemia reperfusion injury: ST-segment resolution (STR) and QRS score, and corrected TIMI frame count(cTFC).
Key secondary outcomes
To evaluate the relationship between other glycemic parameters (HbA1c, HOMA-R) and the following surrogate endpoints of ischemic reperfusion injury: STR, QRS score, and cTFC.
Clinical outcomes including death, recurrent MI, stroke, heart failure or any repeat revascularization at 30 days and 12 months as well as angiographic outcomes at 12 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with STEMI within 24hours from onset amenable to primary PCI.
2)Age: 20 years old or more.
3)Regardless of glycemic profile.
Key exclusion criteria
1)Patients suspected to have type 1 diabetes
2)Pregnant or child-bearing potential woman
3)Inability to provide informed consent
4)Patients with history of previous myocardial infarction
5)Poor recording of electrocardiography unsuitable for analysis
6)Cardiogenic shock receiving mechanical circulatory and respiratory support device
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Tsuchida |
Organization
Niigata City General Hospital
Division name
Department of Cardiology
Zip code
Address
463-7 Shumoku, Chuo-ku, 950-1197 Niigata, Japan
TEL
025-281-5151
keitsuchida97@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Tsuchida |
Organization
Niigata City General Hospital
Division name
Department of Cardiology
Zip code
Address
463-7 Shumoku, Chuo-ku, 950-1197 Niigata, Japan
TEL
025-281-5151
Homepage URL
keitsuchida97@gmail.com
Sponsor or person
Institute
Department of Cardiology, Niigata City General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 05 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CGMS is equipped in each patient after primary PCI. STR and QRS score are calculated with electrocardiograms recorded on arrival, 60minutes and 1 week after primary PCI. The association between glycemic variability and STR/QRS score is evaluated. In addition, the impact of glycemic variability on 12-month cardiovascular outcomes is investigated.
Management information
Registered date
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2014 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016372
