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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | |||
Condition | type B aortic dissection | ||
Classification by specialty |
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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 | |
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Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |