NCT00661752

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

3 months

First QC Date

April 8, 2008

Last Update Submit

August 25, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Image quality of quarter-time WBR images is equivalent/superior to full-time FBP

    March 2008

Secondary Outcomes (1)

  • Image quality of quarter-time WBR is equivalent/superior to half-time WBR

    March 2008

Study Arms (4)

FBP studies

standard filtered backprojection image processing/reconstruction of full-time acquisition data

Device: quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.CardiacDevice: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - 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.CardiacDevice: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - 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

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

Interventions

Comparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR

Also known as: WBR, wide-beam reconstruction, Xpress3.Cardiac
FBP studiesQuarter-time stresshalf-time WBR

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.

Also known as: WBR, wide-beam reconstruction, Xpress3.Cardiac
FBP studiesQuarter-time resthalf-time WBR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male and female patients referred to St. Luke's NM lab. for clinically indicated myocardial perfusion SPECT

You may qualify if:

  • Patient is clinically stable
  • Patient is able to tolerate additional 8 minutes of scanning
  • Patient is willing to undergo additional 8 minutes of scanning

You may not qualify if:

  • Unstable patient
  • Non-consenting patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Gordon DePuey, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 18, 2008

Study Start

May 1, 2007

Primary Completion

August 1, 2007

Study Completion

January 1, 2008

Last Updated

August 26, 2008

Record last verified: 2008-08