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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031590
Receipt No. R000036069
Scientific Title 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
Date of disclosure of the study information 2018/03/05
Last modified on 2018/09/04

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Basic information
Public title 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
Acronym VA risks of papaverine used FFR
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Okabe Yoshitaka
Organization municipal tsuruga hospital
Division name cardiology
Zip code
Address misimacho
TEL 09056828475
Email yosi3305@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okabe Yoshitaka
Organization hospital
Division name cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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