Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System (Hawkeye)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587730
Recruitment Status : Terminated (Recruiting or enrolling participants has halted prematurely and will not resume.)
First Posted : January 7, 2008
Last Update Posted : April 23, 2015
Information provided by:
Mayo Clinic

December 21, 2007
January 7, 2008
April 23, 2015
July 2001
August 2004   (Final data collection date for primary outcome measure)
The overall comparisons of the agreement between conventional SPECT imaging and the GE Hawkeye system will be completed using McNemar's test. [ Time Frame: Measured/Compared at time of each scan. ]
Same as current
Complete list of historical versions of study NCT00587730 on Archive Site
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. [ Time Frame: Measured/Compared at time of study ]
Same as current
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Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System
Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System
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).
Not Provided
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Cardiac Disease
Device: GE Attenuation Corrected Hawkeye Camera
GE Hawkeye AC system and 360˚ camera orbit
Active Comparator: Clinical SPECT
GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.
Intervention: Device: GE Attenuation Corrected Hawkeye Camera
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2004
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Todd D. Miller, MD/Professor of Medicine, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Todd D Miller, MD Mayo Clinic
Mayo Clinic
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP