UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027417 |
|---|---|
| Receipt number | 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 | 2020/11/19 12:02:15 |
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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
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
kunihikokiuchi@yahoo.co.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medcine
Institute
Department
Personal name
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
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
http://dx.doi.org/10.1002/joa3.12454
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1002/joa3.12454
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
| 2020 | Year | 11 | Month | 19 | Day |
Baseline Characteristics
A consecutive 10 paroxysmal atrial fibrillation patients after the cryoballoon ablation (CBA) were enrolled. The patient characteristics are shown in Table 1. The mean age was 54 +/- 15 years old and 9 patients were male. The mean left atrial diameter (LAD) and left ventricular ejection fraction (LVEF) were 38 +/- 6 mm and 62 +/- 9 %, respectively. As for the procedural data, the CBA procedure time and fluoroscopy time were 167 +/- 38 min and 46 +/- 20 mm, respectively. Radiofrequency touch-up ablation for the RIPV was performed in 1 (10%) of 10 patients. The cardiac rhythm was sinus rhythm (SR) at the time of the PET/MRI and LGE-MRI acquisition in all patients.
Participant flow
This study was an open-label, single-arm, prospective clinical trial and was registered with the University Hospital Medical Information Network-Clinical Trial Registry (UMIN-CTR) (UMIN000027417) and Japan Registry of Clinical Trials (jRCT) (jRCTs 052180024). The protocol for this study was approved by the local ethics committees of the institutions and conformed to the provisions of the Declaration of Helsinki (Committee of 17 August 2019, Approval No.C180014).The detailed protocol has been described previously.(7) The primary endpoint was the visualization of the atrial inflammation by the PET/MRI. The secondary endpoint was the atrial fibrosis following atrial inflammation.
Adverse events
No adverse events.
Outcome measures
We assess whether the atrial inflammation caused by CBA could be visualized by PET/MRI and whether it was associated with the followingfibrosis in AF patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030960
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