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.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587730
First received: December 21, 2007
Last updated: January 4, 2008
Last verified: December 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Resource links provided by NLM:


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
Active Comparator: Clinical SPECT
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014