UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013399 |
|---|---|
| Receipt number | R000015608 |
| Scientific Title | The association between ambulatory blood pressure and recurrence of colonic diverticular bleeding; a prospective observational study |
| Date of disclosure of the study information | 2014/03/12 |
| Last modified on | 2019/03/29 18:48:50 |
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Basic information
Public title
The association between ambulatory blood pressure and recurrence of colonic diverticular bleeding; a prospective observational study
Acronym
The association between ambulatory blood pressure and recurrence of colonic diverticular bleeding
Scientific Title
The association between ambulatory blood pressure and recurrence of colonic diverticular bleeding; a prospective observational study
Scientific Title:Acronym
The association between ambulatory blood pressure and recurrence of colonic diverticular bleeding
Region
| Japan |
Condition
Condition
Colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether ambulatory blood pressure can predict recurrence of colonic diverticular bleeding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between recurrence rate of colonic diverticular bleeding and ambulatory blood pressure
Key secondary outcomes
1.The association between recurrence rate of colonic diverticular bleeding and circadian rhythm in blood pressure
2.The association between recurrence rate of colonic diverticular bleeding and morning blood pressure surge
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients admitted for hematochezia
2.Patients with colonic diverticular bleeding which is diagnosed by colonoscopy
3.Patients with essential hypertension treated by medication, or a systolic blood pressure of 140 mm Hg or higher or diastolic blood pressure of 90 mm Hg or higher, or represent marked fluctuation of a blood pressure
4.Patients between 20 and 85 years old
5.Patients who provided written informed consent
Key exclusion criteria
1.Patients without overt gastrointestinal bleeding
2.Patients with upper gastrointestinal bleeding
3.Patients with lower gastrointestinal bleeding other than colonic diverticular bleeding
4.Patients with pregnancy
5.Patients with acute cardiovascular or cerebrovascular disease
6.Patients with malignant neoplasia
7.Patients with prior colectomy
8.Patients with vasculitis syndrome, Raynaud's disease, arteriovenous shunt for hemodialysis in the bilateral arms
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yamada-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yamada-a@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2014 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015608
