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However, the main limitation of these observational cohort studies is that they are not really ""testing"" the role of screening and the benefit of any interventions that may follow. The optimal method of evaluating a screening test is a randomized trial. Recently, two clinical trials have now addressed this question by randomizing asymptomatic DM patients to screening or not using cardiac SPECT 19, 20 or CCTA 21. The Detection of Ischemia in Asymptomatic Diabetics (DIAD) study was a multicenter prospective trial in the U.S. and Canada of asymptomatic patients with Pentamorphone type 2 DM without known or suspected CHD 19. Between July 2000 and August 2002, 1,123 subjects were randomized to either screening rest/stress SPECT (n= 561) or continued on the standard of care (n= 562) and followed for approximately 5 yrs. The mean DM duration at randomization was 8.2 ��7.1 yrs in the screened group and 8.9 �� 6.9 yrs in the control group (Table 2). Preliminary findings revealed that 22% (113/522) of the screening SPECT images were consistent with silent ischemia although only 6% (n= 33) had moderate or large stress perfusion defects 19. The primary outcome of cardiac death or non-fatal MI over the mean 4.8 yrs follow up was relatively low with a cumulative cardiac click here event rate of 2.9% or 0.6% per year 20. Most importantly, the number of cardiac events did not differ between the screening SPECT and standard of care groups. Only 7 non-fatal MI and 8 cardiac deaths (2.7%) occurred in the screened group and 10 non-fatal MI and 7 cardiac deaths (3.0%) among the standard of care group (HR, 0.88; 95%CI, 0.44-1.88; p= 0.73). Coronary angiography (4.4% vs. 0.5%; p LBH589 rate of coronary angiography (14% vs. 12%; p= NS) and coronary revascularization (5.5% vs. 7.8%; p= 0.14) were comparable in the screened and unscreened group after the conclusion of the 5-year follow-up period. Importantly, during the course of the trial there was a significant and equivalent increase in primary prevention medical treatments, including aspirin, statins and angiotensin converting enzyme inhibitors, in both groups. Thus, data from the DIAD study suggest that screening asymptomatic type 2 DM patients with SPECT stress testing did not reduce the cardiac events compared to contemporary standard of care. Table 2. Cardiovascular outcomes after randomization of asymptomatic individuals with diabetes mellitus to screening for evaluation of coronary heart disease.