UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027840 |
|---|---|
| Receipt number | 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 17:26:34 |
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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
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
konosuke.s@med.tohoku.ac.jp
Sponsor or person
Institute
Cardiovascular division, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031894
