Prognostic study of cardiac and renal events in Japanese patients with chronic kidney disease and cardiovascular risk using myocardial perfusion SPECT : J-ACCESS 3 study design

Cardiovascular disease is the leading cause of morbidity and mortality in patients with chronic kidney disease. Recent studies have indicated that the incidence of cardiovascular disease increases inversely with estimated glomerular filtration rate. Although coronary angiography is considered the gold standard for detecting coronary artery disease, contrast-induced nephropathy or cholesterol microembolization remain serious problems; therefore, a method of detecting coronary artery disease without renal deterioration is desirable. From this viewpoint, stress myocardial perfusion single photon emission computed tomography (SPECT) might be useful for patients with chronic kidney disease. We recently performed the Japanese Assessment of Cardiac Events and Survival Study by Quantitative Gated SPECT (J-ACCESS) investigating patients with suspected or extant coronary artery disease and the J-ACCESS 2 study of patients with diabetes. The findings from these studies showed that SPECT can detect coronary artery disease and help to predict future cardiac events. Thus, we proposed a multicenter, prospective cohort study called “J-ACCESS 3” in patients with chronic kidney disease and cardiovascular risk. The study aimed at predicting cardiovascular and renal events based on myocardial perfusion imaging and clinical backgrounds. We began enrolling patients in J-ACCESS 3 at 74 facilities from April 2009 and will continue to do so until 31 March 2010, with the aim of having a cohort of 800 patients. These will be followed up for three years. The primary endpoints will be cardiac death and sudden death. The secondary endpoints will comprise any cardiovascular or renal events. This study will be completed in 2013. Here, we describe the design of the J-ACCESS 3 study.