UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Significance of Reversed R Wave Progression in Right Precordial Leads
Title of the study (Brief title)	Significance of Reversed R Wave Progression
Region	Japan

Condition
Condition	Heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the significance of reversed R wave progression (RRWP) in clinical practice.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	frequency of RRWP breakdown of diseases in RRWP
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	ECGs obtained from the patients aged >=20 years at our hospital between November 2009 and August 2012.
Key exclusion criteria	each patient was counted only once and only one ECG per patient was included in the analysis.
Target sample size	10000

Research contact person
Name of lead principal investigator	Hiroki Isono
Organization	Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital
Division name	General internal medicine
Address	3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL	029-853-2371
Email	isono-tuk@umin.ac.jp

Public contact
Name of contact person	Shigeyuki Watanabe
Organization	Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital
Division name	Department of Cardiology
Address	3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL	029-853-2371
Homepage URL
Email	watanabe.s.gn@u.tsukuba.ac.jp.

Sponsor
Institute	Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital
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)

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	2016 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 27 Day
Anticipated trial start date	2014 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	retrospective study We had a conference presentation at the 77th annual scientific meeting of the Japanese circulation society.

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029168