UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005177 |
|---|---|
| Receipt number | R000006149 |
| Scientific Title | Japanese prospective multicenter study on outpatient cardiac rehabilitation after the percutaneous coronary intervention |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2014/09/08 13:13:59 |
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Basic information
Public title
Japanese prospective multicenter study on outpatient cardiac rehabilitation after the percutaneous coronary intervention
Acronym
J-REHAB PCI
Scientific Title
Japanese prospective multicenter study on outpatient cardiac rehabilitation after the percutaneous coronary intervention
Scientific Title:Acronym
J-REHAB PCI
Region
| Japan |
Condition
Condition
Patients with ischemic heart disease except for acute myocardial infarction received an elective or emergency percutaneous coronary intervention (PCI) with a drug eluting stent (DES) within 1 month
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of outpatient cardiac rehabilitation for patients received a PCI with a DES
Basic objectives2
Others
Basic objectives -Others
Efficacy/Safety
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac death (including sudden death) or ischemic heart disease
Key secondary outcomes
1) cardiac disease requiring hospitalization, 2) exercise tolerability, 3) Quality of Life (SF-36, SDS, SAS), 4) change of cardiac risk factors (HbA1c, TG, HDL-C, high-sensitive CRP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
outpatient cardiac rehabilitation followed the cardiac rehabilitation program
Interventions/Control_2
usual care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ischemic heart disease except for acute myocardial infarction received an elective or emergency PCI with a DES within 1 month and have two or more following risk factors, 1) diabetes mellitus or glucose intolerance, 2) hypertension, 3) hyperlipidemia (LDL≥140mg/dL, HDL<40mg/dL, TG≥150mg/dL at enrollment) 4) BMI≥25, 5) smoking. In addition, patients who have no contraindication to the rehabilitation.
Key exclusion criteria
1) Patients received a PCI after acute myocardial infarction, 2) Patients who experienced cerebrovascular disease or orthopedic disease which are impediments to the exercise, 3) chronic renal failure (Cr>3.0mg/dL), 4) hepatopathy (GPT>200U/L), 5) other diseases which are impediments to the exercise, 6) CABG within 3 month, 7) future plan of CAGB, 8) patients who are difficult to receive the outpatient rehabilitation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi GOTO |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Division
Zip code
Address
5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan
TEL
06-6833-5012
kkatayam@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi GOTO |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Division
Zip code
Address
5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan
TEL
06-6833-5012
Homepage URL
kkatayam@ncvc.go.jp
Sponsor or person
Institute
ational Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
| 2011 | Year | 03 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2014 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006149
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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