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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001939
Receipt No. R000002360
Scientific Title Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting
Date of disclosure of the study information 2009/05/10
Last modified on 2009/05/03

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Basic information
Public title Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting
Acronym Safety of exercise after coronary stenting
Scientific Title Safety of Early Exercise Training in Patients Underwent Elective Coronary Stenting
Scientific Title:Acronym Safety of exercise after coronary stenting
Region
Japan

Condition
Condition stable angina
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the incidence of ST after elective coronary stenting.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of ST within 30 days
Key secondary outcomes major adverse cardiovascular event (MACE), complication rate, and exercise continuation rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 exercise training group
Interventions/Control_2 non-exercise training group
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 underwent successful coronary stenting electively
Key exclusion criteria hemodialysis, uncontrollable hypertention, myocardial infarction (MI) within 4 weeks, symptomatic heart failure, hemorrhagic diatheses, severe valvular heart or pulmonary disease, dementia, or inability to exercise, residual stenosis of target lesion >30%, symptomatic main vessel or side branch occlusions, acute or threatened closure, access site-related complications before enrollment, persistent chest pain or new ST-segment deviation, or final coronary flow less than TIMI (Thrombolysis In Myocardial Infarction) grade 3
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimitsu Soga
Organization Kokura Memorial Hospital
Division name Department of Cardiology
Zip code
Address 1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name Department of Cardiology
Zip code
Address
TEL 093-921-2231
Homepage URL
Email

Sponsor
Institute Yoshimitsu Soga
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 10 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
2004 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 03 Day
Last modified on
2009 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002360

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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