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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027840
Receipt No. R000031894
Scientific Title Temporal changes in blood pressure variability and autonomic nervous activity in patients with type B aortic dissections
Date of disclosure of the study information 2017/07/01
Last modified on 2018/12/05

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Basic information
Public title Temporal changes in blood pressure variability and autonomic nervous activity in patients with type B aortic dissections
Acronym A relationship between BPV and ANS in patients with acute aortic dissections.
Scientific Title Temporal changes in blood pressure variability and autonomic nervous activity in patients with type B aortic dissections
Scientific Title:Acronym A relationship between BPV and ANS in patients with acute aortic dissections.
Region
Japan

Condition
Condition type B aortic dissection
Classification by specialty
Cardiovascular surgery Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the time-course of changes in ANS activity and BPV in patients treated with medical treatment, including after TEVAR.
Basic objectives2 Others
Basic objectives -Others To clarify the relationship between BPV and ANS activity.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time-course of changes in autonomic nervous activity
Key secondary outcomes Time-course of changes in blood pressure variability

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with acute aortic dissecsion (Stanford type B)
(2)Patients treated with medical treatment, including after TEVAR.
(3)Age: over 20 yrs
Key exclusion criteria (1)Patients treated with open-chest surgery.
(2)Age: under 20 yrs
(3)History of atrial fibrillation
(4)Frequent supraventricular and ventricular arrhythmias
(5)Patients with a pacemaker
(6)Patients on dialysis
(7)History of cardiovascular surgery including stent grafting
(8)Patinets with congenital connective tissue disorder
(9)Patinets with dysautomia

Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Konosuke Sasaki
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular division
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7226
Email konosuke.s@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Konosuke Sasaki
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular division
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7226
Homepage URL
Email konosuke.s@med.tohoku.ac.jp

Sponsor
Institute Cardiovascular division, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization JSPS
Organization
Division
Category of Funding Organization Japanese Governmental office
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
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
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031894

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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