title: Rationale and design of J-ACCESS 4: prognostic impact of reducing myocardial ischemia identified using ECG-gated myocardial perfusion SPECT in Japanese patients with coronary artery disease.
abstract: BACKGROUND
  The findings of our recent study entitled, "Japanese Assessment of Cardiac Events and Survival Study by Quantitative Gated SPECT (J-ACCESS)" showed that myocardial perfusion single photon emission computed tomography (MPS) can detect coronary artery disease (CAD) and help to predict future cardiac events in patients with suspected or extant CAD. However, the extent of the benefit conferred by percutaneous coronary intervention (PCI) as an initial management strategy compared with optimal medical therapy remains controversial. Little evidence supports the notion that myocardial ischemia identified using MPS is an alternative target of coronary revascularization to reduce the likelihood of developing cardiac events.
  
  
  METHODS
  The multicenter, prospective cohort J-ACCESS 4 study aims to clarify the prognostic impact of reducing myocardial ischemia determined using electrocardiogram-gated MPS in Japanese patients with coronary artery disease. We started to register patients in J-ACCESS 4 at 74 facilities during June 2012 and will continue to do so until December 2013 or until the cohort comprises 500 patients who will participate in the study from one month before, until two months after stress/rest MPS assessment. Imaging data, the background of the patients including coronary risk factors and treatment before MPS assessments will be analyzed. The patients will undergo coronary revascularization within two months after MPS and/or receive appropriate medical therapy. The second stress/rest MPS will be performed from 4 to 10 months after coronary revascularization or registration. They will be followed up for over one year after the second MPS assessment. The primary endpoints will be cardiac death, sudden death of unknown cause, non-fatal myocardial infarction, and hospitalization for heart failure. The secondary endpoints will comprise death due to all causes including non-cardiac death and any cardiovascular events. This study will be completed in 2015. Here, we describe the design of the J-ACCESS 4 study.
authors.affiliation: Cardiovascular Center, Nagoya Daini Red Cross Hospital, Aichi, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Nanasato
authors.affiliation: Department of Nuclear Medicine, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Department of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujita
authors.affiliation: Division of Cardiology, Department of Medicine, Ohmihachiman Community Medical Center, Shiga, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Zen
authors.affiliation: Division of Cardiology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Shun
authors.initials: S
authors.lastname: Kohsaka
authors.affiliation: Second Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido, Japan.
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Hashimoto
authors.affiliation: Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Moroi
authors.affiliation: Division of Cardiology, Funabashi Municipal Medical Center, Chiba, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Fukuzawa
authors.affiliation: Department of Cardiology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Taishiro
authors.initials: T
authors.lastname: Chikamori
authors.affiliation: Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Nishimura
authors.affiliation: Department of Cardiology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Yamashina
authors.affiliation: Osaka National Hospital, Osaka, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Kusuoka
authors.affiliation: Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hirayama
authors.affiliation: Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. Electronic address: nisimura@koto.kpu-m.ac.jp.
authors.forename: Tsunehiko
authors.initials: T
authors.lastname: Nishimura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055426:Cardiac-Gated Single-Photon Emission Computer-Assisted Tomography; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000628:therapy; D004562:Electrocardiography; D005080:Exercise Test; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis* / Q000209:etiology / Q000517:prevention & control; D055414:Myocardial Perfusion Imaging; D009204:Myocardial Revascularization; D062645:Percutaneous Coronary Intervention; D011379:Prognosis; D011446:Prospective Studies; D012044:Regression Analysis; D012307:Risk Factors; D013997:Time Factors; D055815:Young Adult
keywords: Cardiovascular diseases; Coronary revascularization; Scintigraphy; Stenosis; Stress test