UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006460 |
|---|---|
| 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 | 2024/06/09 12:43:46 |
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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 | Kiyotaka |
| Middle name | |
| Last name | Kugiyama |
Organization
University of Yamanashi
Division name
Internal medicine II
Zip code
4093898
Address
Shimokato 1110, Chuo, Yamanashi, Japan
TEL
055-273-1111
takanaka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Takamitsu |
| Middle name | |
| Last name | Nakamura |
Organization
University of Yamanashi
Division name
Internal medicine II
Zip code
4093898
Address
Shimokato 1110, Chuo, Yamanashi, Japan
TEL
055-273-9590
Homepage URL
takanaka@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Clinical Trial Management Office
Address
Shimokato1110, Chuo
Tel
81-55-273-1111
d0trial-med@yamanashi.ac.jp
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
http://www.med.yamanashi.ac.jp/clinical /intern02/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.yamanashi.ac.jp/clinical /intern02/
Number of participants that the trial has enrolled
30
Results
There was no clear difference in the incidence of composite endpoints between the two groups.
The response to heart failure therapy was compared with changes in brain natriuretic peptide (BNP) and cardiac troponin T (troponin T) over time during hospitalization showing a trend toward better improvement in cardiac failure biomarkers in the remote conditioning group.
Results date posted
| 2024 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 heart failure cases with left ventricular ejection fraction >40% were enrolled.
Participant flow
Patients were treated with diuretics, nitrates, ACE inhibitors/angiotensin II receptor blockers, carperitide, etc., according to the degree of cardiac function, depending on the condition of each patient. Patients with a left ventricular ejection fraction of 40% or greater on echocardiography at the time of admission were included in the study. The exclusion criteria were serious infection or organ damage, shock on admission, valvular heart disease, hemodialysis, and left main trunk coronary artery stenosis. 75 of 120 patients met the exclusion criteria, and 30 of these patients consented to receive remote Of the 120 patients, 75 met the exclusion criteria and were assigned 1:1 to the remote conditioning group and 30 to the control group.
Adverse events
No adverse events were observed in both groups.
Outcome measures
1. Impact on heart failure biomarkers (BNP and troponin T measurements at admission and 7-10 days)
Comparison of heart failure biomarkers at study entry showed no difference in BNP (1045+/-774 pg/ml in control group, vs. 1106+/-808 pg/ml in remote conditioning group, p=0.83), myocardial troponin T (0.17+/-0.38ng/ml in control group, vs. remote conditioning group: 0.1+/-0.1 ng/ml, p=0.26), but the rate of change in BNP (control group: -33.9+/-67.5%, vs. remote conditioning group: -68.4+/-17.5%) at 7-10 days after the start of the study was not different. However, the rate of change at 7-10 days after the start of the study showed a trend toward lower heart failure biomarkers in the remote conditioning group: BNP (control: -33.9+/-67.5%, vs. remote conditioning: -68.4+/-17.0%, p=0.07), cardiac troponin T (control: 13.0+/-59.3%, -26.3+/-29.5%, p=0.03), and heart failure biomarkers were lower in the remote conditioning group.
2. Impact on long-term prognosis of heart failure (up to 2 years; average 1.4 years)
During a maximum follow-up of 2 years (mean 1.4 years), 13 (43%) composite endpoints were observed (all-cause mortality in 4 patients, rehospitalization due to recurrent heart failure in 9 patients). The composite endpoint was 5 (33%) in the remote conditioning group and 8 (53%) in the control group, showing a slightly lower trend in the remote conditioning group, but no statistically significant difference.
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
| 2011 | Year | 10 | Month | 01 | Day |
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
| 2024 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007667
