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)

This study has been completed.
Sponsor:
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00661752
First received: April 8, 2008
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Quarter-Time Myocardial Perfusion SPECT

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Image quality of quarter-time WBR images is equivalent/superior to full-time FBP [ Time Frame: March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Image quality of quarter-time WBR is equivalent/superior to half-time WBR [ Time Frame: March 2008 ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661752

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

No publications provided

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
Study First Received: April 8, 2008
Last Updated: August 25, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014