UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the risk factors for ventricular arrhythmias secondary to QT prolongation induced by papaverine injection during coronary flow reserve studies using a 4Fr angio-catheter
Title of the study (Brief title)	VA risks of papaverine used FFR
Region	Japan

Condition
Condition	ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	examinethe type of background likely to cause ventricular arrythmias
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ventricular arrhythmia
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	iscemic heart disease
Key exclusion criteria	renal failure
Target sample size	200

Research contact person
Name of lead principal investigator	Okabe Yoshitaka
Organization	municipal tsuruga hospital
Division name	cardiology
Address	misimacho
TEL	09056828475
Email	yosi3305@yahoo.co.jp

Public contact
Name of contact person	Okabe Yoshitaka
Organization	hospital
Division name	cardiology
Address	misimacho
TEL	0770223611
Homepage URL
Email	yosi3305@yahoo.co.jp

Sponsor
Institute	municipal tsuruga hospital
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
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	2018 Year 03 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 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	no

Management information
Registered date	2018 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036069