Protocol for Evaluation of Quarter-Time Cardiac Imaging: 5-Minutes Rest and 3-Minutes Stress Wide Beam Reconstruction (WBR) Versus Full-Time Filtered Back Projection (FBP)

Completed

• Conditions: Cardiac Diseases
• Interventions: Device: quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac; Device: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac

• Registration Number: NCT00661752
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

A new, innovative software image processing method, wide beam reconstruction (WBR), utilizes resolution recovery and incorporates Poisson noise-reduction into the reconstruction process of NM images. This method facilitates the reconstruction of low count density myocardial perfusion SPECT images. Preliminary research indicates that SPECT acquisition time consequently can be reduced by 60% (less than 5 minutes) for rest and by 75% (just over 3 minutes) for stress, while tomographic image quality is maintained, or even improved. Such a decrease in image acquisition time decreases patient discomfort during the tomographic acquisition, decreases the opportunity for patient motion, and improves laboratory efficiency.

Detailed Description

Standard full-time SPECT will be processed using FBP and compared to 3-minute stress and 5-minute rest scans processed with WBR. The following scan parameters will be evaluated: image quality; perfusion defect extent, severity, and reversibility; transient ischemic dilatation; left ventricular end-diastolic volume; left ventricular end-systolic volume; left ventricular ejection fraction; and regional wall motion and wall thickening abnormalities. These parameters will be assessed visually by experienced Nuclear physicians (at least 2 blinded readers) and quantitatively using several different commercially available software programs.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-08
• Study Completion: 2008-01
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-25
• Last Update Posted: 2008-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Patient is clinically stable
• Patient is able to tolerate additional 8 minutes of scanning
• Patient is willing to undergo additional 8 minutes of scanning

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Exclusion Criteria

• Unstable patient
• Non-consenting patient

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FBP studies	quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac	standard filtered backprojection image processing/reconstruction of full-time acquisition data
FBP studies	quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac	standard filtered backprojection image processing/reconstruction of full-time acquisition data
half-time WBR	quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac	wide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions
half-time WBR	quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac	wide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions
Quarter-time stress	quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac	4 seconds per stop post-stress SPECT acquisitions reconstructed by the wide-beam reconstruction method
Quarter-time rest	quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac	6 seconds per stop rest SPECT acquisitions reconstructed by the wide-beam reconstruction method

Primary Outcome Measures

Name	Time	Method
Image quality of quarter-time WBR images is equivalent/superior to full-time FBP	March 2008

Secondary Outcome Measures

Name	Time	Method
Image quality of quarter-time WBR is equivalent/superior to half-time WBR	March 2008