UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013399
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yamada-a@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.