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)

August 25, 2008 updated by: St. Luke's-Roosevelt Hospital Center

Quarter-Time Myocardial Perfusion SPECT

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.

Study Overview

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

Enrollment (Actual)

134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FBP studies
standard filtered backprojection image processing/reconstruction of full-time acquisition data
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Image quality of quarter-time WBR images is equivalent/superior to full-time FBP
Time Frame: March 2008
March 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Image quality of quarter-time WBR is equivalent/superior to half-time WBR
Time Frame: March 2008
March 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gordon DePuey, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • quarter-time cardiac SPECT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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