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Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

This study has been terminated.
( Recruiting or enrolling participants has halted prematurely and will not resume. )

Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587730
  Purpose

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).


Condition Intervention Phase
Cardiac Disease
Device: GE Attenuation Corrected Hawkeye Camera
Phase II
Phase III

MedlinePlus related topics:   Heart Attack    Heart Diseases   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:   Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment:   608
Study Start Date:   July 2001
Study Completion Date:   August 2004
Primary Completion Date:   August 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Clinical SPECT: Active Comparator
GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.
Device: GE Attenuation Corrected Hawkeye Camera
GE Hawkeye AC system and 360˚ camera orbit

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587730

Locations
United States, Minnesota
Mayo Clinic    
      Rochester, Minnesota, United States, 55905

Sponsors and Collaborators
Mayo Clinic

Investigators
Principal Investigator:     Todd D Miller, MD     Mayo Clinic    
  More Information


Responsible Party:   Mayo Clinic ( Todd D. Miller, MD/Professor of Medicine )
Study ID Numbers:   1042-01
First Received:   December 21, 2007
Last Updated:   January 4, 2008
ClinicalTrials.gov Identifier:   NCT00587730
Health Authority:   United States: Institutional Review Board

Keywords provided by Mayo Clinic:
heart disease  
cardiac disease  
chest pain  
myocardial infarction  
heart attack  

Study placed in the following topic categories:
Heart Diseases
Pain
Infarction
Myocardial Infarction
Chest Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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