UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021393 |
|---|---|
| Receipt number | R000024673 |
| Scientific Title | Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2017/09/11 11:10:57 |
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Basic information
Public title
Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT
Acronym
Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT
Scientific Title
Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT
Scientific Title:Acronym
Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Coronary artery disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Present study is a prospective, single-center, open-label study to observe impact of comprehensive rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome and coronary artery disease by coronary CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of regression, quality and stabilization of coronary plaque after one year
Key secondary outcomes
1.Correlation of serum lipid profile value, the rate of change and regression, quality change of coronary plaque after cardiac rehabilitation
2.Correlation of inflammatory marker value, the rate of change and regression, quality change of coronary plaque after cardiac rehabilitation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients participate in cardiac rehabilitation three times a week for a total one year.
We recommend for the total number of steps to be 8,000 steps or more per day.
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
Acute coronary syndrome
Coronary artery disease
Key exclusion criteria
1.Acute exacerbation, cirrhosis, and liver carcinoma of acute hepatitis nad chronic hepatitis
2. The renal dysfunction (The serum creatinine value is 2.0 mg/dL or more) or the dialytic treatment is being enforced
3. Patients who judged that examination responsibility doctor is improper as object in present study
Target sample size
60
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 Cardiovasacular 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 | Miho Yokoyama |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Cardiovasacular Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
mipocch@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
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024673
