UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039520 |
|---|---|
| Receipt number | R000045071 |
| Scientific Title | Determinants of Left Ventricular Reverse Remodeling following Percutaneous Coronary Intervention in Patients with Systolic Dysfunction |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2020/02/18 07:00:01 |
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Basic information
Public title
Determinants of Left Ventricular Reverse Remodeling following Percutaneous Coronary Intervention in Patients with Systolic Dysfunction
Acronym
Determinants of LVRR following PCI in Patients with Systolic Dysfunction
Scientific Title
Determinants of Left Ventricular Reverse Remodeling following Percutaneous Coronary Intervention in Patients with Systolic Dysfunction
Scientific Title:Acronym
Determinants of LVRR following PCI in Patients with Systolic Dysfunction
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the determinants of left ventricular reverse remodeling following percutaneous coronary intervention in coronary artery disease patients with reduced left ventricular ejection fraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular reverse remodeling at 6 months follow-up left ventriculography
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent percutaneous coronary intervention,
2) Patients with reduced left ventricular systolic function (left ventricular ejection fraction <50% at initial left ventriculography)
Key exclusion criteria
1) Patients without follow-up left ventriculography
2) Patients diagnosed as acute myocardial infarction
3) Patients diagnosed as stress cardiomyopathy
4) Patients who received coronary artery bypass grafting during the follow-up period
5) Patients who received cardiac resynchronization therapy during the follow-up period
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Arihiro |
| Middle name | |
| Last name | Kiyosue |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
kiyosue-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Arihiro |
| Middle name | |
| Last name | Kiyosue |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
kiyosue-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2020 | Year | 02 | Month | 18 | 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
286
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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the presence of left ventricular reverse remodeling at 6 months follow-up left ventriculography
Management information
Registered date
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045071
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
