Coronary Artery DiseasePhase 4NCT00976053
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
A Phase 4 study testing Myocardial perfusion imaging in people with Coronary Artery Disease, run by Aspire Foundation at 1 site in United States.
Trial summary
The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Myocardial perfusion imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2014
- Phase
- Phase 4
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of coronary artery disease
- New or worsening symptoms
- Out-patients and in-hospital patients
Who cannot join
- Creatinine above 2.5 mg%
- PCI within prior 6 months
- Pregnant females
- Cardiomyopathy (LVEF below 40%)
- Significant valvular heart disease
- Body mass index greater than 38
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Cardiovascular Consultants
Kansas City, Missouri, 64111
About this study
Official title: Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)
The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.
- Conditions
- Coronary Artery Disease
- Being tested
- Myocardial perfusion imaging
- Keywords
- Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography
- 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.
Myocardial perfusion imagingProcedure or surgery
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
| Study group | Role | What they receive |
|---|---|---|
| SPECT myocardial perfusion imaging | Active comparator | Not described Receives: Procedure: Myocardial perfusion imaging |
| PET myocardial perfusion imaging | Active comparator | Not described Receives: Procedure: Myocardial perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic failure of SPECT vs PET
Measured: 60 days
Secondary outcomes (4)
Composite of diagnostic or clinical failure
Measured: 12 months
Each of individual components of clinical failure
Measured: 12 months
Relative effect on quality of life
Measured: 3 months, 6 months
Relative direct and downstream costs
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspire Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
- Responsible party
- Principal investigator, Timothy M. Bateman, Aspire Foundation
- Investigators
- Timothy M Bateman, M.D., Principal investigator, Aspire Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976053
- Sponsor's protocol ID
- 09-307
- Status last verified
- Oct 2014
- First submitted
- 11 Sep 2009
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel KK, Al Badarin F, Chan PS, Spertus JA, Courter S, Kennedy KF, Case JA, McGhie AI, Heller GV, Bateman TM. Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients. JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.
PubMed 31326480
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT00976053
- Acronym / sponsor ID
- 09-307
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Aspire FoundationUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Sep 2009 (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 pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPECT myocardial perfusion imaging | Active comparator | Procedure: Myocardial perfusion imaging |
| PET myocardial perfusion imaging | Active comparator | Procedure: Myocardial perfusion imaging |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of coronary artery disease
- New or worsening symptoms
- Out-patients and in-hospital patients
Key exclusion criteria (6 listed)
- Creatinine above 2.5 mg%
- PCI within prior 6 months
- Pregnant females
- Cardiomyopathy (LVEF below 40%)
- Significant valvular heart disease
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 |
|---|---|---|
| Myocardial perfusion imagingRandomization assignment to one of SPECT or PET myocardial perfusion imaging | Procedure or surgery | PET myocardial perfusion imaging, SPECT myocardial perfusion imaging |
Primary outcome
Diagnostic failure of SPECT vs PET
Time frame: 60 days
4 secondary outcomes
Composite of diagnostic or clinical failure
Time frame: 12 months
Each of individual components of clinical failure
Time frame: 12 months
Relative effect on quality of life
Time frame: 3 months, 6 months
Relative direct and downstream costs
Time frame: 3 months, 6 months, 12 months
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 31 Oct 2014.
- Derived from this study: PubMed 31326480Patel KK, Al Badarin F, Chan PS, Spertus JA, Courter S, Kennedy KF, Case JA, McGhie AI, Heller GV, Bateman TM. Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients. JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.
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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, M.D. principal investigator
Aspire Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myocardial perfusion imaging in people with Coronary Artery Disease, run by Aspire Foundation at 1 site 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 3 inclusion and 6 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of SPECT vs PET (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976053, which also lists 1 linked publication.
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 31 Oct 2014; AzTrials last refreshed its copy on 31 Oct 2026.