Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status
NCT ID: NCT04475094
Last Updated: 2020-07-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
75 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-12-23
Study Completion Date
2021-12-31
Brief Summary
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We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.
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Detailed Description
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Myocardial perfusion imaging (MPI) has a well-established role in diagnosis, risk stratification and prognostication in patients with suspected or known coronary artery disease (CAD)(1,2). As the current health-care landscape moves towards rewarding value, there is an increased urgency for determining the role of imaging tests in improving patient-centered outcomes (3-5). Traditionally, the cardiac imaging community has focused on studying "hard outcomes" such as cardiac morbidity and mortality, with relatively little attention on patient-centered health status outcomes (e.g. symptoms, function and quality of life).
While Single Photon Emission Computed Tomography (SPECT) has been a myocardial perfusion imaging (MPI) mainstay for decades, use of Positron Emission Tomography (PET) MPI has been increasing as it offers superior spatial resolution, lower radiation exposure, higher diagnostic accuracy, shorter acquisition times and quantification of myocardial blood flow reserve (MBFR) (6-9). MBFR integrates the hemodynamic effects of microvascular dysfunction, diffuse atherosclerotic disease and epicardial stenosis on myocardial tissue perfusion, and as such is more likely to correlate with patient's anginal symptoms, functional status and quality of life (10,11). MBFR measured by PET MPI has been shown to provide independent and incremental prognostic value for major adverse cardiac events beyond perfusion defect analysis, but has not been evaluated for its association with symptoms, function and quality of life (although in a post-hoc analysis of 171 patients with known CAD undergoing PET MPI enrolled in the ASPIRE study at our center, higher MBFR was significantly associated with lower anginal burden as measured by the Seattle Angina Questionnaire (SAQ; unpublished data, being presented at ASNC 2018)) (8,10,12-15). Among 329 patients, Taqueti et al demonstrated that patients with low global MBFR were less likely to require subsequent heart failure hospitalizations and cardiac deaths if treated with early revascularization with bypass surgery, but not percutaneous coronary intervention (PCI), as compared with medical management; however the low number of events and the small sample size were major limiting factors (10). More recently, among 12,594 patients undergoing PET MPI, we demonstrated that MBFR \<1.8 may help identify patients with a survival benefit from early revascularization within 90 days of the index MPI test. (unpublished data, being presented at AHA 2018). In a sub-study of the PACIFIC study, Driessen et al showed strong correlation of change in MBFR post revascularization with change in FFR; providing further support for non-invasively measured MBFR as a potential measure to target intervention, similar to FFR, which needs invasive measurement on coronary angiography (16).
To further elucidate the mechanism of action by which MBFR could be used to target management for ischemic heart disease, we propose a study of serial PET MPI in 75 patients undergoing coronary stenting to evaluate the association of changes in MBFR with changes in patients' health status. About a quarter to half of stable CAD patients treated with PCI continue to have angina and poor quality of life after stenting (17-19) This may be because stenting is only directed at epicardial stenoses, while many patients have concomitant microvascular disease. While there has been some data where serial PET MPI studies have been used to look at changes in perfusion defect sizes and flows with anti-ischemic medications and statins (20-24) it is not known whether these changes are associated with improved outcomes. We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.
While Single Photon Emission Computed Tomography (SPECT) has been a myocardial perfusion imaging (MPI) mainstay for decades, use of Positron Emission Tomography (PET) MPI has been increasing as it offers superior spatial resolution, lower radiation exposure, higher diagnostic accuracy, shorter acquisition times and quantification of myocardial blood flow reserve (MBFR) (6-9). MBFR integrates the hemodynamic effects of microvascular dysfunction, diffuse atherosclerotic disease and epicardial stenosis on myocardial tissue perfusion, and as such is more likely to correlate with patient's anginal symptoms, functional status and quality of life (10,11). MBFR measured by PET MPI has been shown to provide independent and incremental prognostic value for major adverse cardiac events beyond perfusion defect analysis, but has not been evaluated for its association with symptoms, function and quality of life (although in a post-hoc analysis of 171 patients with known CAD undergoing PET MPI enrolled in the ASPIRE study at our center, higher MBFR was significantly associated with lower anginal burden as measured by the Seattle Angina Questionnaire (SAQ; unpublished data, being presented at ASNC 2018)) (8,10,12-15). Among 329 patients, Taqueti et al demonstrated that patients with low global MBFR were less likely to require subsequent heart failure hospitalizations and cardiac deaths if treated with early revascularization with bypass surgery, but not percutaneous coronary intervention (PCI), as compared with medical management; however the low number of events and the small sample size were major limiting factors (10). More recently, among 12,594 patients undergoing PET MPI, we demonstrated that MBFR \<1.8 may help identify patients with a survival benefit from early revascularization within 90 days of the index MPI test. (unpublished data, being presented at AHA 2018). In a sub-study of the PACIFIC study, Driessen et al showed strong correlation of change in MBFR post revascularization with change in FFR; providing further support for non-invasively measured MBFR as a potential measure to target intervention, similar to FFR, which needs invasive measurement on coronary angiography (16).
To further elucidate the mechanism of action by which MBFR could be used to target management for ischemic heart disease, we propose a study of serial PET MPI in 75 patients undergoing coronary stenting to evaluate the association of changes in MBFR with changes in patients' health status. About a quarter to half of stable CAD patients treated with PCI continue to have angina and poor quality of life after stenting (17-19) This may be because stenting is only directed at epicardial stenoses, while many patients have concomitant microvascular disease. While there has been some data where serial PET MPI studies have been used to look at changes in perfusion defect sizes and flows with anti-ischemic medications and statins (20-24) it is not known whether these changes are associated with improved outcomes. We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.
Conditions
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Coronary Artery Disease
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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COHORT
All patients will have had a clinically-indicated PET revealing at least one reversible perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks post-successful coronary artery stenting.
Rubidium-82
Intervention Type
DRUG
Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.
Seattle Angina Questionnaire-7
Intervention Type
BEHAVIORAL
Consented subjects will complete a SAQ-7.
Rose Dyspnea Scale
Intervention Type
BEHAVIORAL
Consented subjects will complete a RDS.
Interventions
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Rubidium-82
Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.
Intervention Type
DRUG
Seattle Angina Questionnaire-7
Consented subjects will complete a SAQ-7.
Intervention Type
BEHAVIORAL
Rose Dyspnea Scale
Consented subjects will complete a RDS.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Myocardial Perfusion PET
Eligibility Criteria
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Inclusion Criteria
1. The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study shows at least one reversible perfusion defect; and
2. The MBFR measurement meets quality control criteria for accuracy; and
3. The patient has completed a baseline SAQ-7 and RDS survey with a SAQ-7 Angina Frequency Score \<100 (indicating the occurrence of at least some angina symptoms over the past 4 weeks); and
4. The patient has undergone a successful coronary artery stenting within 60 days after the PET scan without a significant change in clinical condition between the time of baseline PET MPI test and PCI; and 5. The patient agrees to undergo a second PET scan 3-6 weeks after coronary artery stenting and to complete a second SAQ-7 and RDS survey.
2. The MBFR measurement meets quality control criteria for accuracy; and
3. The patient has completed a baseline SAQ-7 and RDS survey with a SAQ-7 Angina Frequency Score \<100 (indicating the occurrence of at least some angina symptoms over the past 4 weeks); and
4. The patient has undergone a successful coronary artery stenting within 60 days after the PET scan without a significant change in clinical condition between the time of baseline PET MPI test and PCI; and 5. The patient agrees to undergo a second PET scan 3-6 weeks after coronary artery stenting and to complete a second SAQ-7 and RDS survey.
Exclusion Criteria
1. EF \<40%
2. Significant aortic stenosis/regurgitation
3. Significant Mitral stenosis/regurgitation)
4. Prior CABG
5. Poor quality base line PET study due one or more technical challenges (e.g. patient motion, imprecise registration of CT and emission data, flows that violate quality criteria, lack of flow augmentation suggestive of an A2A antagonist)
2. Significant aortic stenosis/regurgitation
3. Significant Mitral stenosis/regurgitation)
4. Prior CABG
5. Poor quality base line PET study due one or more technical challenges (e.g. patient motion, imprecise registration of CT and emission data, flows that violate quality criteria, lack of flow augmentation suggestive of an A2A antagonist)
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Cardiovascular Imaging Technologies
INDUSTRY
Sponsor Role
lead
Responsible Party
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Timothy M. Bateman, MD
Medical Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Saint Luke's Hospital Imaging Center
Kansas City, Missouri, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Related Links
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Other Identifiers
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19-080
Identifier Type: -
Identifier Source: org_study_id
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