UMIN-CTR Clinical Trial

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
Last 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
1st 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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015608