UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of comprehensive cardiac rehabilitation program on stabilization of coronary plaque after acute coronary syndrome.
Title of the study (Brief title)	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	Hiroyuki Daida
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovascular 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	Katsumi Miyauchi
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011751