UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of comprehensive cardiac rehabilitation program on regression and stabilization of coronary plaque after acute coronary syndrome by coronary CT
Title of the study (Brief title)	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	Hiroyuki Daida
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovasacular Medicine
Address	2-1-1 Hongo, Bunkyo-ku Tokyo Japan
TEL	03-3813-3111
Email	daida@juntendo.ac.jp

Public contact
Name of contact person	Miho Yokoyama
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovasacular Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024673