<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/NCT02250963</url>
  </required_header>
  <id_info>
    <org_study_id>GNUH-PANDA-01</org_study_id>
    <nct_id>NCT02250963</nct_id>
  </id_info>
  <brief_title>Prognostic Accuracy of Coronary CT and Dobutamine Stress Echocardiography in Patient Undergoing Non-cardiac Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gyeongsang National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gyeongsang National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography&#xD;
      coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries</measure>
    <time_frame>1 month</time_frame>
    <description>Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve.&#xD;
Postoperative hard cardiac events were defined as cardiac death, non-fatal myocardial infarction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of DES vs. CTCA in the prediction of the perioperative all cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.</measure>
    <time_frame>1 month</time_frame>
    <description>Perioperative all cardiovascular events were defined as cardiac death, non-fatal myocardial infarction, pulmonary edema, ventricular fibrillation, new onset atrial fibrillation with hemodynamic compromise, complete heart block, pulmonary embolism, and prophylactic revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.</measure>
    <time_frame>1 month</time_frame>
    <description>Incremental diagnostic accuracy changes with DES and/or CTCA compared to RCRI alone.&#xD;
Incremental diagnostic accuracy includes the area under the curve comparison analysis, integrated discrimination improvement, and net reclassification improvement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diagnostic accuracy of blood viscosity test in the prediction of the perioperative cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.</measure>
    <time_frame>1 month</time_frame>
    <description>preoperative blood viscosity test using BVD (blood viscosity dynamic) system</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">220</enrollment>
  <condition>Cardiac Complications of Care (&amp; [Post Operative])</condition>
  <arm_group>
    <arm_group_label>DSE</arm_group_label>
    <description>Patients, who underwent Dobutamine Stress Echocardiography (DSE)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTCA</arm_group_label>
    <description>Computed tomography coronary angiography is going to perform with a 64-slice system (Brilliance 64, Philips Healthcare, Best, the Netherlands).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        non-cardiac surgery patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elective surgery&#xD;
&#xD;
          2. Intermediate or high-risk noncardiac surgeries 1) intermediate risk surgery:&#xD;
             intrathoracic, intraperitoneal, orthopedic,head and neck, and prostate 2) high risk&#xD;
             surgery: vascular&#xD;
&#xD;
          3. Revised cardiac risk index score ≥1 (more than one of the following criteria) 1)&#xD;
             vascular surgery, intraperitoneal, intrathoracic surgery 2) history of ischemic heart&#xD;
             disease 3) history of heart failure 4) history of cerebrovascular disease 5) diabetes&#xD;
             with insulin treatment 6) chronic kidney disease (serum creatinine &gt; 2.0 mg/dL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Need for emergency surgery&#xD;
&#xD;
          2. Active cardiac conditions 1) recent (within 1 month) myocardial infarction 2) acute&#xD;
             decompensated heart failure 3) severe valvular disease 4) fatal cardiac arrhythmia 5)&#xD;
             acute pulmonary embolism 6) acute myocarditis&#xD;
&#xD;
          3. Relative contraindications or immeasurable coronary stenosis of the CTCA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gyeongsang National University Hospital</name>
      <address>
        <city>Jinju</city>
        <state>Gyeongsangnam-Do</state>
        <zip>660-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Ahn JH, Park JR, Min JH, Sohn JT, Hwang SJ, Park Y, Koh JS, Jeong YH, Kwak CH, Hwang JY. Risk stratification using computed tomography coronary angiography in patients undergoing intermediate-risk noncardiac surgery. J Am Coll Cardiol. 2013 Feb 12;61(6):661-8. doi: 10.1016/j.jacc.2012.09.060.</citation>
    <PMID>23391198</PMID>
  </reference>
  <reference>
    <citation>American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine; Society for Vascular Surgery; Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF. 2009 ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery. J Am Coll Cardiol. 2009 Nov 24;54(22):e13-e118. doi: 10.1016/j.jacc.2009.07.010. No abstract available. Erratum In: J Am Coll Cardiol. 2012 Jun 12;59(24):2306.</citation>
    <PMID>19926002</PMID>
  </reference>
  <reference>
    <citation>Das MK, Pellikka PA, Mahoney DW, Roger VL, Oh JK, McCully RB, Seward JB. Assessment of cardiac risk before nonvascular surgery: dobutamine stress echocardiography in 530 patients. J Am Coll Cardiol. 2000 May;35(6):1647-53. doi: 10.1016/s0735-1097(00)00586-6.</citation>
    <PMID>10807472</PMID>
  </reference>
  <reference>
    <citation>Labib SB, Goldstein M, Kinnunen PM, Schick EC. Cardiac events in patients with negative maximal versus negative submaximal dobutamine echocardiograms undergoing noncardiac surgery: importance of resting wall motion abnormalities. J Am Coll Cardiol. 2004 Jul 7;44(1):82-7. doi: 10.1016/j.jacc.2004.03.049.</citation>
    <PMID>15234412</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dobutamine Stress Echocardiography</keyword>
  <keyword>Computed tomography coronary angiography</keyword>
  <!-- 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/NCT02250963
org study id: GNUH-PANDA-01
nct id: NCT02250963
lead sponsor: 
has dmc: Yes
This study aimed to compare dobutamine stress echocardiography (DES) with computed tomography
      coronary angiography (CTCA) in patients with undergoing intermediate to high risk noncardiac
      surgery.
observational model: Case-Only
time perspective: Prospective
measure: Diagnostic accuracy of DES vs. CTCA in the prediction of the postoperative hard cardiac events in patients undergoing intermediate to high risk noncardiac surgeries
time frame: 1 month
description: Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve.
Postoperative hard cardiac events were defined as cardiac death, non-fatal myocardial infarction.
measure: Diagnostic accuracy of DES vs. CTCA in the prediction of the perioperative all cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.
time frame: 1 month
description: Perioperative all cardiovascular events were defined as cardiac death, non-fatal myocardial infarction, pulmonary edema, ventricular fibrillation, new onset atrial fibrillation with hemodynamic compromise, complete heart block, pulmonary embolism, and prophylactic revascularization.
measure: Diagnostic accuracy of DES and/or CTCA compared to revised cardiac risk score (RCRI) alone.
time frame: 1 month
description: Incremental diagnostic accuracy changes with DES and/or CTCA compared to RCRI alone.
Incremental diagnostic accuracy includes the area under the curve comparison analysis, integrated discrimination improvement, and net reclassification improvement.
measure: Diagnostic accuracy of blood viscosity test in the prediction of the perioperative cardiovascular events in patients undergoing intermediate to high risk noncardiac surgeries.
time frame: 1 month
description: preoperative blood viscosity test using BVD (blood viscosity dynamic) system
arm group label: DSE
description: Patients, who underwent Dobutamine Stress Echocardiography (DSE)
arm group label: CTCA
description: Computed tomography coronary angiography is going to perform with a 64-slice system (Brilliance 64, Philips Healthcare, Best, the Netherlands).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Ahn JH, Park JR, Min JH, Sohn JT, Hwang SJ, Park Y, Koh JS, Jeong YH, Kwak CH, Hwang JY. Risk stratification using computed tomography coronary angiography in patients undergoing intermediate-risk noncardiac surgery. J Am Coll Cardiol. 2013 Feb 12;61(6):661-8. doi: 10.1016/j.jacc.2012.09.060.
PMID: 23391198
citation: American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine; Society for Vascular Surgery; Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF. 2009 ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery. J Am Coll Cardiol. 2009 Nov 24;54(22):e13-e118. doi: 10.1016/j.jacc.2009.07.010. No abstract available. Erratum In: J Am Coll Cardiol. 2012 Jun 12;59(24):2306.
PMID: 19926002
citation: Das MK, Pellikka PA, Mahoney DW, Roger VL, Oh JK, McCully RB, Seward JB. Assessment of cardiac risk before nonvascular surgery: dobutamine stress echocardiography in 530 patients. J Am Coll Cardiol. 2000 May;35(6):1647-53. doi: 10.1016/s0735-1097(00)00586-6.
PMID: 10807472
citation: Labib SB, Goldstein M, Kinnunen PM, Schick EC. Cardiac events in patients with negative maximal versus negative submaximal dobutamine echocardiograms undergoing noncardiac surgery: importance of resting wall motion abnormalities. J Am Coll Cardiol. 2004 Jul 7;44(1):82-7. doi: 10.1016/j.jacc.2004.03.049.
PMID: 15234412
responsible party type: Sponsor