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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021393
Receipt No. 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

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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
Email 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
Email mipocch@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
Nationality of Funding Organization

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024673

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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