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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004842
Receipt No. R000005767
Scientific Title Safety and Efficacy of Exercise Training After Coronary Stenting in Patients with Stable Angina.
Date of disclosure of the study information 2011/01/15
Last modified on 2011/01/08

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Basic information
Public title Safety and Efficacy of Exercise Training After Coronary Stenting in Patients with Stable Angina.
Acronym Safety and Efficacy of Exercise Training After Coronary Stenting in Patients with Stable Angina.
Scientific Title Safety and Efficacy of Exercise Training After Coronary Stenting in Patients with Stable Angina.
Scientific Title:Acronym Safety and Efficacy of Exercise Training After Coronary Stenting in Patients with Stable Angina.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety of exercise training after coronary stenting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of stent thrombosis
Key secondary outcomes 1. MACE (death, MI and stroke)
2. mortality
3. MI
4. stoke
5. unscheduled hospital visit for worsening angina

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria successful elective coronary stenting (defined as residual stenosis of the target lesion < 30% without suboptimal result).
no residual stenosis or scheduled to undergo revascularization and planned administration of oral antiplatelet agents.
Key exclusion criteria hemodialysis, uncontrollable hypertension, unstable angina, myocardial infarction (MI) within 4 weeks, symptomatic heart failure, hemorrhagic diatheses, severe valvular heart disease, dementia, inability to exercise due to orthopedic or neurological limitations
Target sample size 3700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soga Yoshimitsu
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address 3-2-1 Asano Kokurakita-ku Kitakyusyu city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address
TEL
Homepage URL
Email sogacchy@yahoo.co.jp

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization Kokura Memorial Hospital
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
2011 Year 01 Month 15 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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients decided whether to participate in ET by themselves.

Management information
Registered date
2011 Year 01 Month 08 Day
Last modified on
2011 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005767

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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