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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/11/19 |
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 |
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Condition | ||
Condition | atrial fibrillation | |
Classification by specialty |
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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 |
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Interventions/Control_1 | PETMRI was peformed 3days after cryoballoon ablation to assess the degree of inflamation induced by the ablation procedure. | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Prospective interventional study
The patients who underewnet cyoballoon ablation for the atrial fibrillation. |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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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. | ||||||
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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