UMIN-CTR Clinical Trial

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
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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
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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
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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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
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