UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020483 |
|---|---|
| Receipt number | 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 10:52:01 |
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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
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
shokimot@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023656
