UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006038 |
|---|---|
| Receipt number | 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 09:57:18 |
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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
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
ktmmy@juntendo.ac.jp
Sponsor or person
Institute
School of Medicine Juntendo University,Department of Cardiovascular
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007150
