Cardiac DiseasesNCT00661752
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)
An observational study of Cardiac Diseases, run by St. Luke's-Roosevelt Hospital Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases
- What is being tested?
- quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac and quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients referred to St. Luke's NM lab. for clinically indicated myocardial perfusion SPECT
Who may be able to join
- Patient is clinically stable
- Patient is able to tolerate additional 8 minutes of scanning
- Patient is willing to undergo additional 8 minutes of scanning
Who cannot join
- Unstable patient
- Non-consenting patient
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Diseases
- Being tested
- quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac, quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.CardiacDevice
Also called WBR, wide-beam reconstruction, 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.CardiacDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| FBP studies | standard filtered backprojection image processing/reconstruction of full-time acquisition data Receives: 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 | |
| half-time WBR | wide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions Receives: 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 | |
| Quarter-time stress | 4 seconds per stop post-stress SPECT acquisitions reconstructed by the wide-beam reconstruction method Receives: 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 Receives: Device: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality of quarter-time WBR images is equivalent/superior to full-time FBP
Measured: March 2008
Secondary outcomes (1)
Image quality of quarter-time WBR is equivalent/superior to half-time WBR
Measured: March 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Investigators
- Gordon DePuey, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661752
- Sponsor's protocol ID
- quarter-time cardiac SPECT
- Status last verified
- Aug 2008
- First submitted
- 8 Apr 2008
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quarter-Time Myocardial Perfusion SPECT
- ClinicalTrials.gov ID
- NCT00661752
- Acronym / sponsor ID
- quarter-time cardiac SPECT
- Conditions
- Cardiac Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FBP studies | – | Device: quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac, Device: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiacstandard filtered backprojection image processing/reconstruction of full-time acquisition data |
| half-time WBR | – | Device: quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac, Device: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiacwide-beam reconstruction of simulated half-time acquisitions from standard full-time acquisitions |
| Quarter-time stress | – | Device: quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.Cardiac4 seconds per stop post-stress SPECT acquisitions reconstructed by the wide-beam reconstruction method |
| Quarter-time rest | – | Device: quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.Cardiac6 seconds per stop rest SPECT acquisitions reconstructed by the wide-beam reconstruction method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients referred to St. Luke's NM lab. for clinically indicated myocardial perfusion SPECT
Key inclusion criteria (3 listed)
- Patient is clinically stable
- Patient is able to tolerate additional 8 minutes of scanning
- Patient is willing to undergo additional 8 minutes of scanning
Key exclusion criteria (2 listed)
- Unstable patient
- Non-consenting patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quarter-time stress scans reconstructed by WBR (4SPS) - Xpress3.CardiacAlso: WBR, wide-beam reconstruction, Xpress3.CardiacComparison of the diagnostic quality of quarter-time WBR stress with stress studies generated via FBP and half-time WBR | Device | FBP studies, Quarter-time stress, half-time WBR |
| quarter-time rest scans reconstructed by WBR (6/8/10 SPS) - Xpress3.CardiacAlso: WBR, wide-beam reconstruction, Xpress3.CardiacComparison 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. | Device | FBP studies, Quarter-time rest, half-time WBR |
Primary outcome
Image quality of quarter-time WBR images is equivalent/superior to full-time FBP
Time frame: March 2008
1 secondary outcome
Image quality of quarter-time WBR is equivalent/superior to half-time WBR
Time frame: March 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
Related trials for Cardiac Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon DePuey, MD principal investigator
St. Luke's-Roosevelt Hospital Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Diseases, run by St. Luke's-Roosevelt Hospital Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of quarter-time WBR images is equivalent/superior to full-time FBP (time frame: March 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2008.