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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)

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ClinicalTrials.gov Identifier: NCT00661752
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : August 26, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Cardiac Diseases 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

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 Type : Observational
Actual Enrollment : 134 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Quarter-Time Myocardial Perfusion SPECT
Study Start Date : May 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
FBP studies
standard filtered backprojection image processing/reconstruction of full-time acquisition data
Device: 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
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac

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.
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac

half-time WBR
wide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions
Device: 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
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac

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.
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac

Quarter-time stress
4 seconds per stop post-stress SPECT acquisitions reconstructed by the wide-beam reconstruction method
Device: 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
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac

Quarter-time rest
6 seconds per stop rest SPECT acquisitions reconstructed by the wide-beam reconstruction method
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.
Other Names:
  • WBR
  • wide-beam reconstruction
  • Xpress3.Cardiac




Primary Outcome Measures :
  1. Image quality of quarter-time WBR images is equivalent/superior to full-time FBP [ Time Frame: March 2008 ]

Secondary Outcome Measures :
  1. Image quality of quarter-time WBR is equivalent/superior to half-time WBR [ Time Frame: March 2008 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male and female patients referred to St. Luke's NM lab. for clinically indicated myocardial perfusion SPECT
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661752


Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Gordon DePuey, MD St. Luke's-Roosevelt Hospital Center

Responsible Party: E.Gordon DePuey, MD, St.Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00661752     History of Changes
Other Study ID Numbers: quarter-time cardiac SPECT
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases