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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006038
Receipt No. R000007150
Scientific Title Impact of comprehensive cardiac rehabilitation program on regression of atherosclerotic plaque and vascular remodeling
Date of disclosure of the study information 2011/07/25
Last modified on 2013/02/13

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Basic information
Public title Impact of comprehensive cardiac rehabilitation program on regression of atherosclerotic plaque and vascular remodeling
Acronym Impact of exercise therapy on regression of atherosclerotic plaque and vascular remodeling
Scientific Title Impact of comprehensive cardiac rehabilitation program on regression of atherosclerotic plaque and vascular remodeling
Scientific Title:Acronym Impact of exercise therapy on regression of atherosclerotic plaque and vascular remodeling
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Present study is a prospective study to observe the nonpharmacologic therapy that is the combination of the therapeutic exercise and the dietary instruction what influence to exert on the progress of coronary atherosclerotic plaque by the intravascular ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change rate and remodeling index of capacity of coronary artery plaque after six months
Key secondary outcomes 1.Amount of change of capacity of coronary atherosclerotic plaque
2.Quality change of coronary atherosclerotic plaque
3.Amount of change and change rate of lipid profile
4.Correlation of serum lipid profile value after exercise therapy, the change rate, change of capacity of coronary atherosclerotic plaque rate, quality change, and remodeling index
5.Correlation of value of inflammatory marker after exercise therapy, the change rate, and change of capacity of coronary atherosclerotic plaque rate
6.Correlation of change rate, amount, amount of plague change, and change rate of adeponekuchin
7.Amount of change and change rate of area of coronary atherosclerotic plaque of culprit lesion
8.Minimum blood vessel diameter of culprit lesion, amount of change of percent of stenosis, and change rate
9.Major adverse cardio-cerebro-vascular events
10.All cause death

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 comprehensive cardiac rehabilitation program (the nonpharmacologic therapy that is the combination of the therapeutic exercise and the dietary instruction)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Acute coronary syndrome patient
2.Patient that coronary artery plaque exists in leaving from area of the body treated by 5mm or more and same branches
3.Patient who obtained document agreement by intention of patient himself
Key exclusion criteria 1.Target lesion is bypass graft.
2.Cardiogenic shock
3.Acute exacerbation, cirrhosis, and liver carcinoma of acute hepatitis and chronic hepatitis
4.The renal dysfunction (The serum creatinine value is 2.0mg/dL or more) or the dialytic treatment is being enforced.
5.Patient who judged that examination responsibility doctor is improper as object in present study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Daida
Organization School of Medicine Juntendo University
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Miyauchi
Organization School of Medicine Juntendo University
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email ktmmy@juntendo.ac.jp

Sponsor
Institute School of Medicine Juntendo University,Department of Cardiovascular
Institute
Department

Funding Source
Organization The Ministry of Education
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 25 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
2009 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 25 Day
Last modified on
2013 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007150

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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