<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/NCT01719016</url>
  </required_header>
  <id_info>
    <org_study_id>10-05-05-02</org_study_id>
    <nct_id>NCT01719016</nct_id>
  </id_info>
  <brief_title>Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics</brief_title>
  <official_title>Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diagnosis of relative contributions of large artery blockages and microvascular blockages is&#xD;
      very much needed in the treatment of coronary artery disease. In order to achieve this, two&#xD;
      novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings&#xD;
      and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with&#xD;
      pressure and flow readings, are being investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnosis of relative contributions of large artery blockages and microvascular blockages is&#xD;
      very much needed in the treatment of coronary artery disease. In order to achieve this, two&#xD;
      novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings&#xD;
      and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with&#xD;
      pressure and flow readings, are being investigated. The diagnostic parameters will be&#xD;
      correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography&#xD;
      (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantification of relative contributions of large artery disease and microvascular disease</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of relative contributions of large artery disease and microvascular disease</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Cardiac PET, Coronary catheterization</arm_group_label>
    <description>Cardiac PET scan:&#xD;
Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each.&#xD;
Injection of Lexiscan.&#xD;
Coronary catheterization:&#xD;
Pressure and flow readings using Combowire&#xD;
Injection of Adenosine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac PET, Coronary catheterization</intervention_name>
    <description>Patients would under go a Cardiac rest and stress PET scan and include the following drug administration:&#xD;
N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress&#xD;
Lexiscan - stress agent for PET scan&#xD;
Patients would also undergo Coronary catheterization including the following drug administration and device usage:&#xD;
Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA).&#xD;
Adenosine - stress agent during catheterization, 140 ug/Kg/min</description>
    <arm_group_label>Cardiac PET, Coronary catheterization</arm_group_label>
    <other_name>Volcano therapeutics</other_name>
    <other_name>Combomap machine</other_name>
    <other_name>Adenosine</other_name>
    <other_name>Lexiscan</other_name>
    <other_name>N-13 Ammonia</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chest pain and suspected ischemia that needs to be assessed by a stress test&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or above&#xD;
&#xD;
          -  Patients referred to a stress test by a Cardiologist&#xD;
&#xD;
          -  Acute Chest pain, as per patient input.&#xD;
&#xD;
          -  Risk Assessment with prior test results and/or previous history of known chronic&#xD;
             stable CAD.&#xD;
&#xD;
          -  Borderline or discordant stress testing where obstructive CAD remains a concern.&#xD;
&#xD;
          -  New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress&#xD;
             imaging study.&#xD;
&#xD;
          -  Coronary stenosis or anatomic abnormality of uncertain significance.&#xD;
&#xD;
          -  In absence of reliable diagnostic information from another imaging modality.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left ventricular ejection fraction less the 25% determined by gated SPECT imaging&#xD;
&#xD;
          -  Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater&#xD;
             than 2.5 gm/dL.&#xD;
&#xD;
          -  History of type II heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  Significant co-morbid condition that is medically unstable and would make coronary&#xD;
             angiography prohibitive or contraindicated.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Incapacitated for Consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rupak K Banerjee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati , CVAMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Effat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univesity of Cincinnati, University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Imran Arif, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati and University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanan Kerr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Veteran Affairs Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>June 16, 2022</last_update_submitted>
  <last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Rupak K. Banerjee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Reversible ischemia</keyword>
  <keyword>microvascular dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenosine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01719016
org study id: 10-05-05-02
nct id: NCT01719016
lead sponsor: 
has dmc: No
Diagnosis of relative contributions of large artery blockages and microvascular blockages is
      very much needed in the treatment of coronary artery disease. In order to achieve this, two
      novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings
      and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with
      pressure and flow readings, are being investigated.
Diagnosis of relative contributions of large artery blockages and microvascular blockages is
      very much needed in the treatment of coronary artery disease. In order to achieve this, two
      novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings
      and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with
      pressure and flow readings, are being investigated. The diagnostic parameters will be
      correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography
      (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).
observational model: Other
time perspective: Prospective
measure: Quantification of relative contributions of large artery disease and microvascular disease
time frame: 2 years
description: Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).
measure: Quantification of relative contributions of large artery disease and microvascular disease
time frame: 2 years
description: Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.
arm group label: Cardiac PET, Coronary catheterization
description: Cardiac PET scan:
Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each.
Injection of Lexiscan.
Coronary catheterization:
Pressure and flow readings using Combowire
Injection of Adenosine.
intervention type: Procedure
intervention name: Cardiac PET, Coronary catheterization
description: Patients would under go a Cardiac rest and stress PET scan and include the following drug administration:
N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress
Lexiscan - stress agent for PET scan
Patients would also undergo Coronary catheterization including the following drug administration and device usage:
Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA).
Adenosine - stress agent during catheterization, 140 ug/Kg/min
arm group label: Cardiac PET, Coronary catheterization
other name: Volcano therapeutics
other name: Combomap machine
other name: Adenosine
other name: Lexiscan
other name: N-13 Ammonia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rupak K Banerjee, PhD
role: Principal Investigator
affiliation: University of Cincinnati , CVAMC
last name: Mohamed Effat, MD
role: Principal Investigator
affiliation: Univesity of Cincinnati, University Hospital
last name: Imran Arif, MD
role: Principal Investigator
affiliation: University of Cincinnati and University Hospital
last name: Hanan Kerr, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: Rupak K. Banerjee
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Adenosine
sharing ipd: Undecided