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

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.

Ability of the prognostic model of J-ACCESS study to predict cardiac events in a clinical setting: The APPROACH study

“…Coronary revascularization will be the primary indication to improve chest symptoms and the prognosis of patients with moderate to severe myocardial ischemia [6]. J-ACCESS 4 study is in progress to assess the prognostic impact of reducing myocardial ischemia identified using ECG-gated myocardial perfusion SPECT [7]. In the present study, we identified high cardiac risk even without ischemia, and this was usually due to complications with DM and chronic kidney disease (CKD) as well as reduced LV contractility.…”

Prognostic impact of reducing myocardial ischemia identified using ECG-gated myocardial perfusion SPECT in Japanese patients with coronary artery disease: J-ACCESS 4 study

“…The Organizing Committee of the Japanese Assessment of Cardiac Events and Survival Study by Quantitative Gated SPECT (J-ACCESS) 4 planned this multicenter, prospective cohort study. The rationale and design of the J-ACCESS 4 study is described elsewhere [9]. During the registration period between June 1, 2012 and December 30, 2013, 494 patients at 59 institutions who met the inclusion criteria were enrolled in the study one month before, until two months after a first stress/rest MPI.…”

“…All reconstructed short-axis data created at each site were sent to the J-ACCESS site (Osaka, Japan) in Digital Imaging and Communication in Medicine (DICOM) format. An image interpretation committee evaluated digital images in a blinded manner to increase scoring objectivity as described [9]. Summed stress (SSS), summed rest (SRS) and summed difference (SDS) scores were converted into ratios (%) of the total myocardium (%myo stress, %myo rest, and %myo ischemia, respectively).…”

“…The authors are grateful to the physicians and technologists who participated in this study and are listed elsewhere [9].…”

Cardiac Event Risk Stratification Using Nuclear Cardiology in Japanese Patients with Coronary Artery Disease

“…Additionally, ischemic reduction observed on SPECT images was greater with PCI plus optimal medical therapy than with optimal medical therapy alone. In Japan, the J-ACCESS IV trial [36], which is similar to the design of the COURAGE Trial Nuclear Substudy, has been started in order to collect data prospectively. Prior to that, we conducted a retrospective pilot study to investigate a relationship between the ischemic reduction and the onset of cardiac events after treatment in Japanese patients with CAD.…”