- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661752
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
Status
Completed
Conditions
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:
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:
|
|
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:
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:
|
|
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:
|
|
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:
|
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.