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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010031
Receipt No. 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

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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
Email 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
Email ktmmy@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011751

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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