Gated SPECT perfusion imaging for the simultaneous assessment of myocardial perfusion and ventricular function in the BARI 2D trial: an initial report from the Nuclear Core Laboratory.
BACKGROUND
The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial, a National Heart, Lung, and Blood Institute-sponsored study in type 2 diabetic patients with coronary artery disease, completed patient recruitment in March 2005. This trial had a nuclear substudy in addition to many other substudies.


RESULTS
After patient enrollment, adenosine gated single photon emission computed tomography perfusion imaging is performed at years 1 and 3. The images are interpreted at the core laboratory. Among the objectives of the nuclear substudy are (1) to determine the impact of the mode of therapy on left ventricular function, extent of ischemia, and scar; (2) to determine the impact of therapy on the progression/regression of ischemia/scar and changes in left ventricular function between years 1 and 3; and (3) to determine the independent and incremental prognostic value of ischemia, scar, and left ventricular function on the primary and secondary endpoints of the trial in the entire patient population and specified subgroups such as women, elderly patients, and minorities.


CONCLUSIONS
This article describes the methodology and the initial experience of the nuclear core laboratory in this large multicenter trial and provides a summary of variables that are available for future analysis by the working group.
Iskandrian
Ami E
AE
BARI 2D Nuclear Cardiology Core Laboratory, University of Alabama at Birmingham, Birmingham, AL 35294-0006, USA. aiskand@uab.edu
Heo
Jack
J
Mehta
Deval
D
Tauxe
E Lindsey
EL
Yester
Michael
M
Hall
Mary Beth
MB
MacGregor
Joan M
JM
D000241:Adenosine; D002986:Clinical Trials as Topic; D015897:Comorbidity; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology* / Q000601:surgery; D003924:Diabetes Mellitus, Type 2 / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000601:surgery; D015637:Gated Blood-Pool Imaging / Q000706:statistics & numerical data*; D006801:Humans; D011379:Prognosis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods* / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging* / Q000453:epidemiology* / Q000601:surgery
D000241:Adenosine