UMIN-CTR Clinical Trial

Basic information
Public title	The distribuiton of inflamation aseesed by the PETMRI after cryoballoon ablation and AF recurrence
Acronym	Visulaization of inflamation after cryoballoon ablation by the PETMRI
Scientific Title	The distribuiton of inflamation aseesed by the PETMRI after cryoballoon ablation and AF recurrence
Scientific Title:Acronym	Visulaization of inflamation after cryoballoon ablation by the PETMRI
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to clarify whether the degree of inflamation assessed by the PETMRI could be associated with the atrial fibrillaiton recurrence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quantitative analysis of the inflamation induced by cryoballoon albaiton
Key secondary outcomes	atrial fibrillation reucrrence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	PETMRI was peformed 3days after cryoballoon ablation to assess the degree of inflamation induced by the ablation procedure.
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	Prospective interventional study The patients who underewnet cyoballoon ablation for the atrial fibrillation.
Key exclusion criteria	The patients with brochial asthma, chronic kidney disase (eGFR<45 mL/min/1.73m2) and who underwent hemodialysis.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Fukuzawa
Organization	Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name	Division of Cardiovascular Medicine
Zip code
Address	7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5111
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kunihiko Kiuchi
Organization	Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name	Division of Cardiovascular Medicine
Zip code
Address	7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL	078-382-5111
Homepage URL
Email	kunihikokiuchi@yahoo.co.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medcine
Institute
Department

Funding Source
Organization	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medcine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Radiology, Kobe University Graduate School of Medcine
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	2017 Year 07 Month 01 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
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	2016 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2018 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030960

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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