UMIN-CTR Clinical Trial

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
Email	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
Email	kiyosue-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045071