UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016668 |
|---|---|
| Receipt number | R000019344 |
| Scientific Title | Associations between Major Adverse Cardiac Events and Various Parameters in Patients with Cardiovascular Diseases with or without Cardiac Rehabilitation |
| Date of disclosure of the study information | 2015/02/28 |
| Last modified on | 2015/02/28 23:16:11 |
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Basic information
Public title
Associations between Major Adverse Cardiac Events and Various Parameters in Patients with Cardiovascular Diseases with or without Cardiac Rehabilitation
Acronym
Cardiac rehabilitation and MACE
Scientific Title
Associations between Major Adverse Cardiac Events and Various Parameters in Patients with Cardiovascular Diseases with or without Cardiac Rehabilitation
Scientific Title:Acronym
Cardiac rehabilitation and MACE
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the associations between with or without cardiac rehabilitation and major adverse cardiac events (MACE) and various parameters in patients with cardiovascular disease during follow-up period (36 months).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MACE (admission, onset of cardiovascular event, all-cause of death) in patients with and without cardiac rehabilitation during follow-up period (for 36 months)
Key secondary outcomes
Associations between with or without cardiac rehabilitation and various parameters [conventional cardiovascular risk factors (age, gender, obesity, smoking, hypertension, dyslipidemia, diabetes), blood pressure profile, lipid profile, various biomarkers, various hemodynamic and atherosclerotic parameters] during follow-up period (pre, 3, 6, 12, 24 and months).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1.Patients with cardiovascular disease
2.Age is 20 years old or more
3.Patients who gave their informed consent to participate for the present study
Key exclusion criteria
1.Severe liver dysfunction
2.Severe renal dysfunction
3.Ineligible patients according to the judgment by physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
saku-k@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Miura |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
Homepage URL
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Fukuoka University School of Medicine.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 28 | 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
| 2014 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | 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
One hundred patients were enrolled.
Management information
Registered date
| 2015 | Year | 02 | Month | 28 | Day |
Last modified on
| 2015 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019344
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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