UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010031 |
|---|---|
| Receipt number | R000011751 |
| Scientific Title | Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome. |
| Date of disclosure of the study information | 2013/02/25 |
| Last modified on | 2019/02/19 11:35:37 |
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Basic information
Public title
Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome.
Acronym
Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome.
Scientific Title
Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome.
Scientific Title:Acronym
Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome.
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Present study is a randomized, prospective, single-center, open-label study to observe impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome by the integrated backscatter analysis - intravascular ultrasound and Optic Coherence Tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of quality and stabilization of coronary plaque after six months
Key secondary outcomes
1. Change of the fibrous membrane thickness of coronary plaque by OCT
2. The rate of change of coronary plaque volume by IB-IVUS
3. The quality change of coronary plaque
4. Amount of change and change rate of lipid profile
5. Correlation of serum lipid profile value, the rate of change and quality change of coronary plaque after exercise therapy
6. Correlation of inflammatory marker value, the rate of change and quality change of coronary plaque after exercise therapy
7. Correlation of the rate of change, amount, adeponekuchin and quality change of coronary plaque
8.Major adverse cardiovascular events (cardiac death, myocardial infarction, TVR: Target lesion revascularization)
9.All cause death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients randomized in the intensive exercise group perform exercise training under supervision by experienced physicians and exercise physiologists one time weekly for 60 min, four times a week for a total 5 months. The training program is intended to be intensive exercise up to 80% of the individual exercise capacity and resistance training after 1 month.
We recommend for the total number of steps to be 9,000 steps or more per day.
Interventions/Control_2
Patients randomized in the moderate-intensity exercise group perform exercise training under supervision by experienced physicians and exercise physiologists one time for 2 weeks for 60 min for a total 5 months.
We recommend for the total number of steps to be 6,000 steps or more per day.
Interventions/Control_3
Control group is the patients who drop out and do not participate in comprehensive cardiac rehabilitation program.
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 patients
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
Juntendo University, Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
daida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsumi Miyauchi |
Organization
Juntendo University, Graduate School of Medicine
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
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2013 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011751
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