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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020483
Receipt No. R000023656
Scientific Title Randomized controlled trial to examine the influence to vascular endothelial function by eradicating Helicobacter pylori in patients with coronary heart disease
Date of disclosure of the study information 2016/01/07
Last modified on 2019/01/09

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Basic information
Public title Randomized controlled trial to examine the influence to vascular endothelial function by eradicating Helicobacter pylori in patients with coronary heart disease
Acronym Randomized controlled trial of the impact of Helicobacter pylori eradication in coronary heart disease patients
Scientific Title Randomized controlled trial to examine the influence to vascular endothelial function by eradicating Helicobacter pylori in patients with coronary heart disease
Scientific Title:Acronym Randomized controlled trial of the impact of Helicobacter pylori eradication in coronary heart disease patients
Region
Japan

Condition
Condition coronary heart disease
Helicobacter pylori infection
Classification by specialty
Gastroenterology Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the effect of eradication of Helicobacter pylori on vascular endothelial function in patients with coronary heart disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vascular endothelial function
Key secondary outcomes cardiovascular events
inflammatory markers
oxidative stress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 eradication of Helicobacter pylori
Interventions/Control_2 not eradication of Helicobacter pylori
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
90 years-old >
Gender Male
Key inclusion criteria Patients with coronary heart disease requiring percutaneous coronary intervention
Key exclusion criteria 1) Past history of eradication for Helicobacter pylori
2) End stage renal failure on hemodialysis
3) Hemodynamically unstable condition
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Hokimoto
Organization Graduate School of Medical Sciences,
Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL 096-373-5175
Email shokimot@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Hokimoto
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL 096-373-5175
Homepage URL
Email shokimot@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization The Ministry of Education, Science, and Culture in Japan
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 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
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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