Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
This study is currently recruiting participants.
Verified May 2013 by Aspire Foundation
Sponsor:
Aspire Foundation
Collaborators:
BlueCross BlueShield of Kansas City
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by (Responsible Party):
Staci Courter, MA, Aspire Foundation
ClinicalTrials.gov Identifier:
NCT00976053
First received: September 11, 2009
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Symptomatic Coronary Artery Disease |
Procedure: Myocardial perfusion imaging |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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) |
Resource links provided by NLM:
Further study details as provided by Aspire Foundation:
Primary Outcome Measures:
- Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Composite of diagnostic or clinical failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Each of individual components of clinical failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Relative effect on quality of life [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
- Relative direct and downstream costs [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: SPECT myocardial perfusion imaging |
Procedure: Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
|
| Active Comparator: PET myocardial perfusion imaging |
Procedure: Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
|
Eligibility| Ages Eligible for Study: | 30 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of coronary artery disease
- New or worsening symptoms
- Out-patients and in-hospital patients
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976053
Contacts
| Contact: Timothy M Bateman, M.D. | 816-751-8542 | tbateman@cc-pc.com |
| Contact: Staci A Courter, M.A. | 816-531-2842 ext 107 | scourter@cvit.com |
Locations
| United States, Missouri | |
| Saint Luke's Cardiovascular Consultants | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Timothy M Bateman, M.D. 816-751-8542 tbateman@cc-pc.com | |
| Contact: Staci A Courter, M.A. 816-531-2842 ext 107 scourter@cvit.com | |
| Principal Investigator: Timothy M Bateman, M.D. | |
| Sub-Investigator: Iain A McGhie, M.D. | |
Sponsors and Collaborators
Aspire Foundation
BlueCross BlueShield of Kansas City
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Investigators
| Principal Investigator: | Timothy M Bateman, M.D. | Aspire Foundation |
More Information
No publications provided
| Responsible Party: | Staci Courter, MA, Clinical Research Coordinator, Aspire Foundation |
| ClinicalTrials.gov Identifier: | NCT00976053 History of Changes |
| Other Study ID Numbers: | 09-307 |
| Study First Received: | September 11, 2009 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Aspire Foundation:
|
Coronary artery disease Myocardial perfusion imaging Single photon emission computed tomography Positron emission tomography |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013