Coronary Artery DiseaseNCT01373944
Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI
An observational study of Coronary Artery Disease, run by Aspire Foundation at 3 sites in United States.
Trial summary
The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Jan 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred for clinically-indicated myocardial perfusion SPECT
Who may be able to join
- BMI < 35 kg/m2
- LVEF > 40%
- Exercise stress
- Elective out-patients
- No known CAD (>50%) by catheterization
- No history of prior myocardial infarction
Who cannot join
- LBBB
- Pacemaker
- Atrial Fibrillation
- Frequent PAC's or PVC's
- Inability to achieve at least 6 minutes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Saint Luke's Cardiovascular Imaging Center
Kansas City, Missouri, 64111
Saint Luke's North Cardiovascular Imaging Center
Kansas City, Missouri, 64154
Saint Luke's East Cardiovascular Imaging Center
Lee's Summit, Missouri, 64086
About this study
Official title: Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT
The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.
- Conditions
- Coronary Artery Disease
- Keywords
- MPI, SPECT, Stress-Only, Spectrum Dynamics Camera, Anger
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stress Only SPECT MPI with Anger Camera | Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the traditional Anger camera | |
| Stress Only SPECT MPI with SD Camera | Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the Spectrum Dynamics camera system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Failure
Diagnostic failure is defined by a composite of need for additional downstream testing (anger SPECT, MPI PET, stress echocardiography or coronary CT angiography) within 30 days or a coronary angiogram with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.
Measured: 30 days
Secondary outcomes (4)
Necessity to proceed to a rest image
The first of 4 secondary end-points is the need to proceed to a rest image.
Measured: 30 days
Necessity for additional downstream testing
The second of four secondary endpoints the need for additional downstream testing within 30 days to address the same clincial reason for the innitial referral for stress-onoly imaging, in the absence of any changes in clincial status between tests.
Measured: 30 days
Coronary Angiography
The third of four secondary end-points is the occurrence of coronary angiography with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.
Measured: 60 to 90 days
Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging
The fourth of four secondary endpoints is to determine optimal performance of the Spectrum Dynamics camera system for stress only imaging: upright imaging alone, supine imaging alone, or both in terms of primary and secondary endpoints
Measured: 60 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspire Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Spectrum Dynamics, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
- Investigators
- Timothy M Bateman, MD, Principal investigator, Aspire Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373944
- Sponsor's protocol ID
- D-Spect Stress Only
- Status last verified
- Dec 2013
- First submitted
- 14 Jun 2011
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT
- ClinicalTrials.gov ID
- NCT01373944
- Acronym / sponsor ID
- D-Spect Stress Only
- Conditions
- Coronary Artery Disease
- Keywords
- MPI, SPECT, Stress-Only, Spectrum Dynamics Camera, Anger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Aspire FoundationUniversity, hospital or other
- Collaborators
- Spectrum Dynamics, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jun 2011 (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.
The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Only SPECT MPI with Anger Camera | – | –Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the traditional Anger camera |
| Stress Only SPECT MPI with SD Camera | – | –Patients undergoing clinically-indicated stress-only sestamibi studies who are imaged on the Spectrum Dynamics camera system. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred for clinically-indicated myocardial perfusion SPECT
Key inclusion criteria (6 listed)
- BMI < 35 kg/m2
- LVEF > 40%
- Exercise stress
- Elective out-patients
- No known CAD (>50%) by catheterization
Key exclusion criteria (5 listed)
- LBBB
- Pacemaker
- Atrial Fibrillation
- Frequent PAC's or PVC's
- Inability to achieve at least 6 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Failure
Time frame: 30 days
Diagnostic failure is defined by a composite of need for additional downstream testing (anger SPECT, MPI PET, stress echocardiography or coronary CT angiography) within 30 days or a coronary angiogram with no stenoses greater than or equal to 50% severity using quantitative coronary angiography.
4 secondary outcomes
Necessity to proceed to a rest image
Time frame: 30 days
Necessity for additional downstream testing
Time frame: 30 days
Coronary Angiography
Time frame: 60 to 90 days
Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging
Time frame: 60 to 90 days
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 23 Dec 2013.
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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.
Timothy M Bateman, MD principal investigator
Aspire Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Aspire Foundation at 3 sites in United States.
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 6 inclusion and 5 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 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Diagnostic Failure (time frame: 30 days). 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 23 Dec 2013.