Unique ID issued by UMIN | UMIN000006460 |
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Receipt number | 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 10:05:49 |
Effects of ischemic remote conditioning on clinical outcomes in patients with coronary heart disease
Effects of ischemic remote conditioning on clinical outcomes
Effects of ischemic remote conditioning on clinical outcomes in patients with coronary heart disease
Effects of ischemic remote conditioning on clinical outcomes
Japan |
Patients with heart failure or ischemic heart disease
Cardiology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase I,II
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.
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Maneuver |
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.
Non-intervention group: standardized treatment alone.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
500
1st name | |
Middle name | |
Last name | Kiyotaka Kugiyama |
University of Yamanashi
Internal medicine II
Shimokato 1110, Chuo, Yamanashi, Japan
055-273-1111
1st name | |
Middle name | |
Last name | Takamitsu Nakamura |
University of Yamanashi
Internal medicine II
Shimokato 1110, Chuo, Yamanashi, Japan
055-273-9590
University of Yamanashi
Japanese Society for the Promotion of Science
NO
山梨大学医学部附属病院(山梨県)
2011 | Year | 10 | Month | 03 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2011 | Year | 10 | Month | 03 | Day |
2013 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007667
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