UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in incidence of acute coronary syndrome before and after the enactment of legislation banning smoking in public places in Hyogo prefecture
Title of the study (Brief title)	Legislation banning smoking and acute coronary syndrome
Region	Japan

Condition
Condition	Acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Number of patients with acute coronary syndrome treated at the major institutions in Hanshin and Kobe district before and after the enactment of prefectural legislation banning smoking in public places will be compared with those in Gifu prefecture.
Basic objectives2	Others
Basic objectives -Others	Prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of patients with acute coronary syndrome treated at the major institutions in Hanshin-Kobe district and Gifu prefecture, before and after the enactment of Hyogo prefectural legislation banning smoking in public places.
Key secondary outcomes	Changes in proportion of patients with acute coronary syndrome

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hyogo or Gifu residents with acute coronary syndrome transported to specific institutions in the prefectures
Key exclusion criteria	none
Target sample size	4800

Research contact person
Name of lead principal investigator	Hisayoshi Fujiwara
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Higashi Daimotsu-cho, Amagasaki-shi, Hyogo
TEL	06-6482-1521
Email	gifuim-gif@umin.ac.jp

Public contact
Name of contact person	Yukihito Sato
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Higashi Daimotsu-cho, Amagasaki-shi, Hyogo
TEL	06-6482-1521
Homepage URL
Email	yukihito.sato@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki Hospital
Institute
Department

Funding Source
Organization	Pfizer Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Cardiology, Gifu University Graduate School of Medicine
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	兵庫県立尼崎病院　他　阪神神戸地区約35施設、岐阜県約20施設

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 26 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 03 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 01 Day
Date analysis concluded	2016 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The number of ACS admissions did not change from the years 2012 to 2015 in both Hyogo District (1774 in the pre year, 1784 in the first year, and 1720 in the second year) and Gifu Prefecture (1226 in the pre year, 1174 in the first year, and 1206 in the second year). However, a clear reduction was observed in the sub-analysis for Kobe City (895 in the preceding year, 830 (-7.3%) in the first year, and 792 (-11.5%) in the second year). Circ J. 2016 Nov 25;80(12):2528-2532.
Other related information	Date of onset of acute coronary syndrome, patient postal code (first 3 digits only), sex, age, and risk factors at the time of treatment of acute coronary syndrome at the institution will be collected

Management information
Registered date	2012 Year 04 Month 20 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009181