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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006460
Receipt No. R000007667
Scientific Title Effects of ischemic remote conditioning on clinical outcomes in patients with coronary heart disease
Date of disclosure of the study information 2011/10/03
Last modified on 2013/07/19

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Basic information
Public title Effects of ischemic remote conditioning on clinical outcomes in patients with coronary heart disease
Acronym Effects of ischemic remote conditioning on clinical outcomes
Scientific Title Effects of ischemic remote conditioning on clinical outcomes in patients with coronary heart disease
Scientific Title:Acronym Effects of ischemic remote conditioning on clinical outcomes
Region
Japan

Condition
Condition Patients with heart failure or ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effects of remote ischemic conditioning on clinical outcomes for patients with heart failure or ischemic heart disease. Enrolled patients are randomely assigned to receive ischemic remote conditioning with standardized treatment or standardized treatment alone, and are prospectively followed up for 5 years. Standardized therapies are based on the guideline of the Japanese Circulation Society.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes All enrolled patients are prospectively followed up for 5 years or until the occurrence of cardiac events. Cardiac events include cardiac death, hospitalization with heart failure, arrhythmia, non-fatal myocardial infarction, unstable angina required coronary revascularization.
Key secondary outcomes Endothelial function of brachial artery (FMD), intima-media thickness (IMT) of carotid arteries, %fractional shortning and %ejection fraction measured by cardiac ultrsaound are evaluated at the enrollment, 1 week, and 1 months after enrollment. Blood sampling are preformed at the enrollment, 1 week and 1 month after enrollment for measurement of inflammatory markers, and angiogenic factors.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention group: remote ischemic conditioning + standardized treatment.
Method: Intermittent arm ischaemia through four cycles of 5-minuites infl ation and 5-minuites defl ation of a blood-pressure cuf for 3 days.
Interventions/Control_2 Non-intervention group: standardized treatment alone.
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 admitted to University of Yamanashi Hospital and fulfilled with following inclusion criteria.
(1) Age; 20 years and older.
(2) Male and female.
(3) Heartfailure or ischemic heart
disease.
Key exclusion criteria Patients are excluded with following exclusion criteria.
(1) Patients on Hemodialysis therapy and with blood access on upper arm.
(2) Patients with severe complications and malignancy.
(3) Patients with decreased blood flow or trauma on upper arm.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Kugiyama
Organization University of Yamanashi
Division name Internal medicine II
Zip code
Address Shimokato 1110, Chuo, Yamanashi, Japan
TEL 055-273-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takamitsu Nakamura
Organization University of Yamanashi
Division name Internal medicine II
Zip code
Address Shimokato 1110, Chuo, Yamanashi, Japan
TEL 055-273-9590
Homepage URL
Email

Sponsor
Institute University of Yamanashi
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 山梨大学医学部附属病院(山梨県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 03 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 Enrolling by invitation
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2016 Year 09 Month 01 Day
Date of closure to data entry
2016 Year 09 Month 01 Day
Date trial data considered complete
2016 Year 10 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 03 Day
Last modified on
2013 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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