UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033468 |
|---|---|
| Receipt number | R000038163 |
| Scientific Title | The association between cardiac arrhythmia and vascular endothelial function |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2022/01/24 08:47:30 |
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Basic information
Public title
The association between cardiac arrhythmia and vascular endothelial function
Acronym
The association between cardiac arrhythmia and vascular endothelial function
Scientific Title
The association between cardiac arrhythmia and vascular endothelial function
Scientific Title:Acronym
The association between cardiac arrhythmia and vascular endothelial function
Region
| Japan |
Condition
Condition
Tachyarrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if the irregular pulse wave evoked by cardiac arrhythmia affects vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function measured by RH-PAT, and circulating biomarkers.
In cases who underwent catheter ablation for arrhythmia, 6 months after the operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Catheter ablation
Interventions/Control_2
none
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have cardiac arrhythmia (cf. atrial flutter, atrial fibrillation, multiple atrial or ventricular premature contractions, and atrial tachycardia), or healthy normal subjects
Key exclusion criteria
Subjects who suffer peripheral arterial disease
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5365
sasano.bi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5365
Homepage URL
sasano.bi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2018 | Year | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038163
