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) - Full Text View

Sponsored by:	St. Luke's-Roosevelt Hospital Center
Information provided by:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT00661752

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

MedlinePlus related topics: Heart Diseases Nuclear Scans

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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 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.
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 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.
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
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.

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

Responsible Party:	St.Luke's-Roosevelt Hospital Center ( E.Gordon DePuey, MD )
Study ID Numbers:	quarter-time cardiac SPECT
Study First Received:	April 8, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00661752
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases
Stress

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009