UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Helicobacter pylori infection Influence the Adverse Cardiovascular Events
Title of the study (Brief title)	HP infection Influence the Adverse Cardiovascular Events
Region	Japan

Condition
Condition	Coronary heart disease
Classification by specialty	Cardiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To examine the effect of Helicobacter pylori infection on adverse cardiovascular events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse Cardiovascular Events
Key secondary outcomes	inflammatory markers

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with coronary heart diseaase requring 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	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City
TEL	096-373-5175
Email	sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	sueta-d@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 01 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 27 Day
Anticipated trial start date	2019 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2019 Year 01 Month 28 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040662