<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04475094</url>
  </required_header>
  <id_info>
    <org_study_id>19-080</org_study_id>
    <nct_id>NCT04475094</nct_id>
  </id_info>
  <brief_title>Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status</brief_title>
  <official_title>Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular Imaging Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiovascular Imaging Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We propose to perform PET MPI studies in patients before and after stenting to evaluate&#xD;
      changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof)&#xD;
      in symptoms, functional status and quality of life. This will help to understand the role of&#xD;
      MBFR in patient selection for coronary angiography and stenting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial perfusion imaging (MPI) has a well-established role in diagnosis, risk&#xD;
      stratification and prognostication in patients with suspected or known coronary artery&#xD;
      disease (CAD)(1,2). As the current health-care landscape moves towards rewarding value, there&#xD;
      is an increased urgency for determining the role of imaging tests in improving&#xD;
      patient-centered outcomes (3-5). Traditionally, the cardiac imaging community has focused on&#xD;
      studying &quot;hard outcomes&quot; such as cardiac morbidity and mortality, with relatively little&#xD;
      attention on patient-centered health status outcomes (e.g. symptoms, function and quality of&#xD;
      life).&#xD;
&#xD;
      While Single Photon Emission Computed Tomography (SPECT) has been a myocardial perfusion&#xD;
      imaging (MPI) mainstay for decades, use of Positron Emission Tomography (PET) MPI has been&#xD;
      increasing as it offers superior spatial resolution, lower radiation exposure, higher&#xD;
      diagnostic accuracy, shorter acquisition times and quantification of myocardial blood flow&#xD;
      reserve (MBFR) (6-9). MBFR integrates the hemodynamic effects of microvascular dysfunction,&#xD;
      diffuse atherosclerotic disease and epicardial stenosis on myocardial tissue perfusion, and&#xD;
      as such is more likely to correlate with patient's anginal symptoms, functional status and&#xD;
      quality of life (10,11). MBFR measured by PET MPI has been shown to provide independent and&#xD;
      incremental prognostic value for major adverse cardiac events beyond perfusion defect&#xD;
      analysis, but has not been evaluated for its association with symptoms, function and quality&#xD;
      of life (although in a post-hoc analysis of 171 patients with known CAD undergoing PET MPI&#xD;
      enrolled in the ASPIRE study at our center, higher MBFR was significantly associated with&#xD;
      lower anginal burden as measured by the Seattle Angina Questionnaire (SAQ; unpublished data,&#xD;
      being presented at ASNC 2018)) (8,10,12-15). Among 329 patients, Taqueti et al demonstrated&#xD;
      that patients with low global MBFR were less likely to require subsequent heart failure&#xD;
      hospitalizations and cardiac deaths if treated with early revascularization with bypass&#xD;
      surgery, but not percutaneous coronary intervention (PCI), as compared with medical&#xD;
      management; however the low number of events and the small sample size were major limiting&#xD;
      factors (10). More recently, among 12,594 patients undergoing PET MPI, we demonstrated that&#xD;
      MBFR &lt;1.8 may help identify patients with a survival benefit from early revascularization&#xD;
      within 90 days of the index MPI test. (unpublished data, being presented at AHA 2018). In a&#xD;
      sub-study of the PACIFIC study, Driessen et al showed strong correlation of change in MBFR&#xD;
      post revascularization with change in FFR; providing further support for non-invasively&#xD;
      measured MBFR as a potential measure to target intervention, similar to FFR, which needs&#xD;
      invasive measurement on coronary angiography (16).&#xD;
&#xD;
      To further elucidate the mechanism of action by which MBFR could be used to target management&#xD;
      for ischemic heart disease, we propose a study of serial PET MPI in 75 patients undergoing&#xD;
      coronary stenting to evaluate the association of changes in MBFR with changes in patients'&#xD;
      health status. About a quarter to half of stable CAD patients treated with PCI continue to&#xD;
      have angina and poor quality of life after stenting (17-19) This may be because stenting is&#xD;
      only directed at epicardial stenoses, while many patients have concomitant microvascular&#xD;
      disease. While there has been some data where serial PET MPI studies have been used to look&#xD;
      at changes in perfusion defect sizes and flows with anti-ischemic medications and statins&#xD;
      (20-24) it is not known whether these changes are associated with improved outcomes. We&#xD;
      propose to perform PET MPI studies in patients before and after stenting to evaluate changes&#xD;
      (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in&#xD;
      symptoms, functional status and quality of life. This will help to understand the role of&#xD;
      MBFR in patient selection for coronary angiography and stenting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SAQ-7 Angina Frequency</measure>
    <time_frame>3-8 weeks</time_frame>
    <description>The primary study objective is to estimate the association of change from baseline in MBFR with SAQ-7 Angina Frequency scores, adjusting for baseline MBFR, baseline SAQ and other patient factors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in MBFR</measure>
    <time_frame>3-8 weeks</time_frame>
    <description>Secondary objective is to estimate the association of change in MBFR with adjusted SAQ-7 Physical Limitation, Quality of Life and Summary scores and Rose Dyspnea Scores (RDS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extent of Epicaridal Stenoses</measure>
    <time_frame>3-8 weeks</time_frame>
    <description>Exploratory objectives include estimating the association of the extent of epicardial stenoses (vs. microvascular disease) at baseline with post-stent MBFR, SAQ-7 and RDS scores, adjusting for baseline.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>COHORT</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rubidium-82</intervention_name>
    <description>Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.</description>
    <arm_group_label>COHORT</arm_group_label>
    <other_name>Myocardial Perfusion PET</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Seattle Angina Questionnaire-7</intervention_name>
    <description>Consented subjects will complete a SAQ-7.</description>
    <arm_group_label>COHORT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rose Dyspnea Scale</intervention_name>
    <description>Consented subjects will complete a RDS.</description>
    <arm_group_label>COHORT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients will have had a clinically-indicated PET revealing at least one reversible&#xD;
        perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks&#xD;
        post-successful coronary artery stenting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study&#xD;
             shows at least one reversible perfusion defect; and&#xD;
&#xD;
          2. The MBFR measurement meets quality control criteria for accuracy; and&#xD;
&#xD;
          3. The patient has completed a baseline SAQ-7 and RDS survey with a SAQ-7 Angina&#xD;
             Frequency Score &lt;100 (indicating the occurrence of at least some angina symptoms over&#xD;
             the past 4 weeks); and&#xD;
&#xD;
          4. The patient has undergone a successful coronary artery stenting within 60 days after&#xD;
             the PET scan without a significant change in clinical condition between the time of&#xD;
             baseline PET MPI test and PCI; and 5. The patient agrees to undergo a second PET scan&#xD;
             3-6 weeks after coronary artery stenting and to complete a second SAQ-7 and RDS&#xD;
             survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. EF &lt;40%&#xD;
&#xD;
          2. Significant aortic stenosis/regurgitation&#xD;
&#xD;
          3. Significant Mitral stenosis/regurgitation)&#xD;
&#xD;
          4. Prior CABG&#xD;
&#xD;
          5. Poor quality base line PET study due one or more technical challenges (e.g. patient&#xD;
             motion, imprecise registration of CT and emission data, flows that violate quality&#xD;
             criteria, lack of flow augmentation suggestive of an A2A antagonist)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Krishna Patel, MD</last_name>
    <phone>216-776-2196</phone>
    <email>kpatel@saint-lukes.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Staci Courter, MA</last_name>
    <phone>816-531-2842</phone>
    <phone_ext>107</phone_ext>
    <email>scourter@cvit.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Saint Luke's Hospital Imaging Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Timothy M Bateman, MD</last_name>
      <phone>816-531-2842</phone>
      <phone_ext>102</phone_ext>
      <email>tbateman@cvit.com</email>
    </contact>
    <contact_backup>
      <last_name>Staci A Courter, MA</last_name>
      <phone>816-751-8542</phone>
      <phone_ext>107</phone_ext>
      <email>scourter@cvit.com</email>
    </contact_backup>
    <investigator>
      <last_name>Krishna Patel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Case, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Hospital-Level-PRO-Based-PM-for-Patients-Undergoing-non-Emergent-PCI_Public-Comment-Summary-Report.pdf</url>
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    <citation>Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ; American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4;127(22):2233-49. doi: 10.1161/CIR.0b013e3182949a2e. Epub 2013 May 6. No abstract available.</citation>
    <PMID>23648778</PMID>
  </reference>
  <reference>
    <citation>Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002 Jul 2;106(1):43-9. doi: 10.1161/01.cir.0000020688.24874.90.</citation>
    <PMID>12093768</PMID>
  </reference>
  <reference>
    <citation>McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.</citation>
    <PMID>25991011</PMID>
  </reference>
  <reference>
    <citation>Rose GA, Blackburn H. Cardiovascular survey methods. Monogr Ser World Health Organ. 1968;56:1-188. No abstract available.</citation>
    <PMID>4972212</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiovascular Imaging Technologies</investigator_affiliation>
    <investigator_full_name>Timothy M. Bateman, MD</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>Myocardial Blood Flow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04475094
org study id: 19-080
nct id: NCT04475094
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Change in SAQ-7 Angina Frequency
time frame: 3-8 weeks
description: The primary study objective is to estimate the association of change from baseline in MBFR with SAQ-7 Angina Frequency scores, adjusting for baseline MBFR, baseline SAQ and other patient factors.
measure: Change in MBFR
time frame: 3-8 weeks
description: Secondary objective is to estimate the association of change in MBFR with adjusted SAQ-7 Physical Limitation, Quality of Life and Summary scores and Rose Dyspnea Scores (RDS).
measure: Extent of Epicaridal Stenoses
time frame: 3-8 weeks
description: Exploratory objectives include estimating the association of the extent of epicardial stenoses (vs. microvascular disease) at baseline with post-stent MBFR, SAQ-7 and RDS scores, adjusting for baseline.
arm group label: COHORT
description: 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.
intervention type: Drug
intervention name: Rubidium-82
description: Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.
arm group label: COHORT
other name: Myocardial Perfusion PET
intervention type: Behavioral
intervention name: Seattle Angina Questionnaire-7
description: Consented subjects will complete a SAQ-7.
arm group label: COHORT
intervention type: Behavioral
intervention name: Rose Dyspnea Scale
description: Consented subjects will complete a RDS.
arm group label: COHORT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Krishna Patel, MD
phone: 216-776-2196
email: kpatel@saint-lukes.org
last name: Staci Courter, MA
phone: 816-531-2842
phone ext: 107
email: scourter@cvit.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
url: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Hospital-Level-PRO-Based-PM-for-Patients-Undergoing-non-Emergent-PCI_Public-Comment-Summary-Report.pdf
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citation: Rumsfeld JS, Alexander KP, Goff DC Jr, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ; American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4;127(22):2233-49. doi: 10.1161/CIR.0b013e3182949a2e. Epub 2013 May 6. No abstract available.
PMID: 23648778
citation: Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002 Jul 2;106(1):43-9. doi: 10.1161/01.cir.0000020688.24874.90.
PMID: 12093768
citation: McNamara RL, Spatz ES, Kelley TA, Stowell CJ, Beltrame J, Heidenreich P, Tresserras R, Jernberg T, Chua T, Morgan L, Panigrahi B, Rosas Ruiz A, Rumsfeld JS, Sadwin L, Schoeberl M, Shahian D, Weston C, Yeh R, Lewin J. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015 May 19;4(5):e001767. doi: 10.1161/JAHA.115.001767.
PMID: 25991011
citation: Rose GA, Blackburn H. Cardiovascular survey methods. Monogr Ser World Health Organ. 1968;56:1-188. No abstract available.
PMID: 4972212
responsible party type: Principal Investigator
investigator affiliation: Cardiovascular Imaging Technologies
investigator full name: Timothy M. Bateman, MD
investigator title: Medical Director
mesh term: Coronary Artery Disease
sharing ipd: No