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)

Cardiac Diseases Clinical Trial

Official title:

Quarter-Time Myocardial Perfusion SPECT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661752
• Other study ID #: quarter-time cardiac SPECT
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: August 25, 2008
• Start date: May 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2008
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Diseases
• Heart Diseases

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality of quarter-time WBR images is equivalent/superior to full-time FBP		March 2008	No
Secondary	Image quality of quarter-time WBR is equivalent/superior to half-time WBR		March 2008	No