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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033468
Receipt No. 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 2018/07/21

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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
Middle name
Last name Tetsuo Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Physiology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5365
Email sasano.bi@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Physiology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5365
Homepage URL
Email sasano.bi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038163

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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