Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Cardiac Disease Clinical Trial

— Hawkeye  

Official title:

Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00587730
• Other study ID #: 1042-01
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 21, 2007
• Last updated: April 21, 2015
• Start date: July 2001
• Est. completion date: August 2004

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 608
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• GE Attenuation Corrected Hawkeye Camera
GE Hawkeye AC system and 360° camera orbit

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No