Design of prospective study of acute coronary syndrome hospitalization after smoking ban in public places in Hyogo prefecture: comparison with Gifu, a prefecture without a public smoking ban.

Background: Hyogo is the second prefecture, after Kanagawa, to enact a smoking ban in public places in Japan. The effect of this smoking ban on acute coronary syndrome (ACS) has not been evaluated.

Purpose: Changes in the annual number of ACS hospital cases in Hyogo Prefecture, before and after the enactment of the prefectural legislative ban on smoking in public places, are to be compared with those in Gifu Prefecture, where there is no smoking-ban legislation.

Methods: Consecutive Hyogo residents with ACS, admitted to 33 major hospitals in the Hanshin-Awaji-Kobe district, which covers 56% of the population, during the 12 months before implementation of the legislation (April 2012 through March 2013) and during the same 24 months thereafter (April 2013 through March 2015) will be enrolled. Consecutive patients with ACS, who are Gifu residents, treated at the 20 major hospitals in Gifu Prefecture will be enrolled as geographical controls. The primary endpoint is the change in number of ACS admissions from April 2012 through March 2015, considering the periods before and after the smoking-ban legislation in Hyogo prefecture.

Conclusion: Our study has certain strengths: (1) This is the first large Japanese study of ACS registry with smoking-ban legislation. (2) Major hospitals in the Hanshin-Awaji-Kobe district are included. (3) The data will cover 3 years including 1 year before legislation enactment. (4) The data will be compared with those of Gifu Prefecture, where smoking-ban legislation will not be enacted. (5) The very large database makes possible analysis of subgroups based on age and gender.