Attenuation Corrected Cardiac SPECT Using the GE Hawkeye Camera System

NCT00587730 | Terminated Phase 2

• 1 other identifier: 1042-01
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiac Disease

Keywords

heart disease; cardiac disease; chest pain; myocardial infarction; heart attack

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

GE Attenuation Corrected Hawkeye Camera DEVICE

GE Hawkeye AC system and 360˚ camera orbit

Clinical SPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the Charlton Nuclear Cardiology Laboratory for stress Tc-99m sestamibi SPECT

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Diseases; Chest Pain; Myocardial Infarction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Todd D Miller, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: July 1, 2001
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

US (1)