Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

608 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2004-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Clinical SPECT

GE Hawkeye Attenuation Correction Camera is being compared to the approved clinical use SPECT camera.

Group Type ACTIVE_COMPARATOR

GE Attenuation Corrected Hawkeye Camera

Intervention Type DEVICE

GE Hawkeye AC system and 360˚ camera orbit

Interventions

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GE Attenuation Corrected Hawkeye Camera

GE Hawkeye AC system and 360˚ camera orbit

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No