UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005607 |
|---|---|
| Receipt number | R000006626 |
| Scientific Title | Cardiac Preconditioning Effect of Remote Ischemia and Nicorandil in Patients Undergoing Elective Percutaneous Coronary Intervention. |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2015/05/18 10:18:27 |
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Basic information
Public title
Cardiac Preconditioning Effect of Remote Ischemia and Nicorandil in Patients Undergoing Elective Percutaneous Coronary Intervention.
Acronym
RINC study
Scientific Title
Cardiac Preconditioning Effect of Remote Ischemia and Nicorandil in Patients Undergoing Elective Percutaneous Coronary Intervention.
Scientific Title:Acronym
RINC study
Region
| Japan |
Condition
Condition
Patients with stable myocardial ischemia who undergo elective PCI.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of remote ischemic preconditioning (RIPC) and intravenous Nicorandil administration before PCI procedure for patients with stable myocardial ischemia by multi center RCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of patients with acute myocardial infarction associated with PCI employing the 2007 universal definition by the joint ESC-AHA-ACC-WHF task force.
Key secondary outcomes
1. Ischemic event during PCI and 8 months MACE after PCI procedure
2. safety of RIPC and Nicorandil
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Control: Subjects who do not undergo any pre-treatment before PCI.
Interventions/Control_2
RIPC: Subjects who undergo RIPC pre-treatment induced by three 5-minute inflations of a blood pressure cuff to 200mmHg around the upper arm, followed by 5-minute intervals of reperfusion 1 hour before PCI.
Interventions/Control_3
Nicorandil: Subjects who undergo intravenous 4mg Nicorandil administration as a bolus 1 hour before PCI, followed by 6mg/hour.
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. Silent myocardial ischemia or stable angina pectoris patient.
2. Over 20 years old patient.
Key exclusion criteria
1. Acute coronary syndrome patient undergoing emergency PCI.
2. Patient corresponded contra-
indication of intravenous Nicorandil administration.
3. Patient undergoing PCI to chronic total occlusion lesion or patients undergoing PCI with rotablator.
4. Diabetes patient treated with glibenclamide.
5. Patient with AV shunt on the arms
6. Patient whose prognosis is regarded as less than 12 months.
7. Patient considered to be improper to this study by attending doctor.
Target sample size
399
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7349
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihisa Kohno |
Organization
Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
Homepage URL
kunihisakohno@msn.com
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
The Okayama medical foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
赤穂中央病院（兵庫県）、岩国医療センター（山口県）、愛媛県立中央病院（愛媛県）、岡山医療センター（岡山県）、岡山済生会総合病院（岡山県）、岡山市立市民病院（岡山県）、岡山赤十字病院（岡山県）、岡山大学病院（岡山県）、岡山労災病院（岡山県）、岡山ハートクリニック（岡山県）、尾道市民病院（広島県）、香川県立中央病院（香川県）、香川県済生会病院（香川県）、笠岡第一病院（岡山県）、高知医療センター（高知県）、心臓病センター榊原病院（岡山県）、済生会今治病院（愛媛県）、住友別子病院（愛媛県）、高松赤十字病院（香川県）、津山中央病院（岡山県）、姫路赤十字病院（兵庫県）、福山市民病院（広島県）、福山循環器病院（広島県）、松山市民病院（愛媛県）、三豊総合病院（香川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 16 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006626
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
