Cardiac Disease
Conditions
Keywords
heart disease, cardiac disease, chest pain, myocardial infarction, heart attack
Brief summary
The accuracy of stress single photon emission computed tomography (SPECT) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. A recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (AC) camera systems in a cardiac phantom showed the best performance with the GE Hawkeye (a hybrid gamma camera-CT scanner) and the University of Michigan M-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. In this study we will combine the strengths of these two systems (GE Hawkeye AC system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress SPECT. These patients will undergo SPECT imaging both with conventional methodology and the GE Hawkeye system. The conventional study will be interpreted and reported in the usual clinical fashion. The GE Hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. The primary study hypothesis is that AC will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (MI). Clinical data and noninvasive test results (history of MI, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to MI (true-positive).
Interventions
DEVICEGE Attenuation Corrected Hawkeye Camera
GE Hawkeye AC system and 360˚ camera orbit
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients referred to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT
Exclusion criteria
* Prior PTCA or CABG * Left bundle branch block (LBBB) or paced ventricular rhythm * Clinically significant valvular heart disease * Hypertrophic or idiopathic dilated cardiomyopathy * Atrial fibrillation or frequent atrial or ventricular ectopy (defined as \>20% ectopic beats * History of MI * ECG evidence of MI * Chest circumference \>55 inches
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test. | Measured/Compared at time of each scan. |
Secondary
| Measure | Time frame |
|---|---|
| Comparisons of categorical factors between the 2 tests will also be completed using McNemar's test, continuous factors will be completed using a paired t-test if the differences are normally distributed. | Measured/Compared at time of study |
Countries
United States
Outcome results
None listed