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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027417
Receipt No. R000030960
Scientific Title The distribuiton of inflamation aseesed by the PETMRI after cryoballoon ablation and AF recurrence
Date of disclosure of the study information 2017/07/01
Last modified on 2020/05/21

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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 Koji
Middle name
Last name Fukuzawa
Organization Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name Division of Cardiovascular Medicine
Zip code 650-0017
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 Kunihiko
Middle name
Last name Kiuchi
Organization Department of Internal Medicine, Kobe University Graduate School of Medcine
Division name Division of Cardiovascular Medicine
Zip code 650-0017
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 The Ethics Committee at Kobe university hospital
Address 7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
Tel 078-382-6669
Email kainyu@med.kobe-u.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
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 10
Results 
SUV max on the PV antrum was significantly higher than that on the healthy LA wall. The volume of the atrial inflammation was strongly correlated with that of the atrial fibrosis.
Results date posted
2020 Year 05 Month 21 Day
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
2017 Year 12 Month 15 Day
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
2019 Year 12 Month 10 Day
Date trial data considered complete
2019 Year 12 Month 15 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2020 Year 05 Month 21 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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