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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)

NCT ID: NCT00661752

Last Updated: 2008-08-26

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

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Cardiac Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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FBP studies

standard filtered backprojection image processing/reconstruction of full-time acquisition data

quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR

quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.

half-time WBR

wide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions

quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR

quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.

Quarter-time stress

4 seconds per stop post-stress SPECT acquisitions reconstructed by the wide-beam reconstruction method

quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR

Quarter-time rest

6 seconds per stop rest SPECT acquisitions reconstructed by the wide-beam reconstruction method

quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac

Intervention Type DEVICE

Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.

Interventions

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quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac

Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR

Intervention Type DEVICE

quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac

Comparison of the diagnostic quality of 6 SPS quarter-time rest acquisitions with FBP and half-time WBR rest studies; simulated 8 SPS and 10 SPS quarter-time rest acquisitions are also compared to FBP and half-time WBR rest studies.

Intervention Type DEVICE

Other Intervention Names

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WBR wide-beam reconstruction Xpress3.Cardiac WBR wide-beam reconstruction Xpress3.Cardiac

Eligibility Criteria

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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

Exclusion Criteria

* Unstable patient
* Non-consenting patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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St.Luke's-Roosevelt Hospital Center

Principal Investigators

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Gordon DePuey, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Other Identifiers

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quarter-time cardiac SPECT

Identifier Type: -

Identifier Source: org_study_id