<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/NCT03265041</url>
  </required_header>
  <id_info>
    <org_study_id>CT coronary post CABG</org_study_id>
    <nct_id>NCT03265041</nct_id>
  </id_info>
  <brief_title>Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)</brief_title>
  <official_title>Predictors of Long Term Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To detect and evaluate the predictors of graft patency after coronary artery bypass graft&#xD;
      surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery bypass grafting (CABG) is an effective treatment of complex, multi-vessel&#xD;
      coronary artery disease(1) .The majority of these patients receive left internal mammary&#xD;
      artery (IMA) grafts to the left anterior descending (LAD) coronary artery and saphenous vein&#xD;
      grafts (SVGs) or other conduits to the remaining vessels. Based on small studies of selected&#xD;
      groups of patients, it is generally believed that SVGs have a 40% to 50% 10-year patency and&#xD;
      that the LIMA has a 90% to 95% 10-year patency The success of coronary artery bypass grafting&#xD;
      (CABG) is dependent on the long-term patency of the arterial and venous grafts.(2) Graft&#xD;
      failure is a surrogate marker for future cardiac events, including repeat revascularization,&#xD;
      myocardial infarction ,and death(3)(4). Vein graft occlusion in the perioperative period is&#xD;
      due to thrombosis resulting from technical problems. Vein graft occlusion within the first&#xD;
      year is attributed to intimal proliferation, although after 1 year, atherosclerosis is&#xD;
      thought to be the dominant factor (5) . LIMA graft failure was defined as diffuse and &gt;95%&#xD;
      conduit narrowing (&quot;string sign&quot; When IMA graft failure occurs, technical error is the most&#xD;
      common cause in the early postoperative period, while late (and rare) IMA failure include&#xD;
      progressive fibro-intimal proliferation and atherosclerosis either in the IMA graft or in the&#xD;
      native LAD vessel)(6) Traditionally, graft patency has been evaluated with coronary&#xD;
      angiography (ICA) but, since the advent of multi-detector computed tomography (MDCT), the&#xD;
      temptation to use a noninvasive and widely available technique to study coronary artery&#xD;
      bypass graft (CABG) patients has been stronger. The introduction of scanners like 64-slice&#xD;
      and 128-slice upwards-along with new scan protocols opens new perspectives in non-invasive&#xD;
      assessment of graft patency.(7) The pooled sensitivity and specificity of detecting complete&#xD;
      graft occlusions - according to( Barbero et al ,2016) ,was 99% and 99% respectively as&#xD;
      compared to the standard of coronary angiography. (8) Computed tomographic angiography,&#xD;
      labeled as Appropriate test for evaluation of bypass grafts and coronary anatomy (9)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of predictors of long term graft patency following CABG</measure>
    <time_frame>1 year</time_frame>
    <description>a. Primary (main): evaluation of long term predictors of graft patency following coronary artery bypass graft surgery&#xD;
Clinical risk factors e.g Age, gender, smoking, Diabetus mellitus, hypertension, Dyslipidemia, chronic kidney disease, congestive heart failure, medications especially antiplatelet and statin therapy, beta-blockers and calcium channel blockers .&#xD;
Biochemical risk factors e.g HDL, LDL, Total cholesterol level&#xD;
Angiographic risk factors : competitive flow and degree of stenosis in the native vessels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of re-hospitalization rate following CABG</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between type of the graft and graft patency</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>multi-slice CT coronary angiography and coronary angiography</intervention_name>
    <description>multi-slice CT coronary angiography to evaluate graft number and patency validated by coronary angiography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        • All patients underwent coronary artery bypass graft surgery more than one year ago&#xD;
        complaining of chest pain presented to Assuit university heart center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients underwent coronary artery bypass graft surgery more than one year ago&#xD;
             complaining of chest pain are included in the study from September 2017 to September&#xD;
             2018&#xD;
&#xD;
          -  Written consent, free and informed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Renal insufficiency (serum creatinine &gt;1.6 mg/dl).&#xD;
&#xD;
               -  Contrast hypersensitivity.&#xD;
&#xD;
               -  Irregular heart rhythm (e.g. Atrial fibrillation).&#xD;
&#xD;
               -  Inability to hold breath for at least 10 seconds&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Harskamp RE, Alexander JH, Ferguson TB, Hager R, Mack MJ, Englum B, et al. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical OutcomesCLINICAL PERSPECTIVE. Circulation [Internet]. 2016;133(2):131-8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26647082%5Cnhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC4814323%5Cnhttp://circ.ahajournals.org/lookup/doi/10.1161/CIRCULATIONAHA.115.015549</citation>
  </reference>
  <reference>
    <citation>Di Lazzaro D, Crusco F. CT angio for the evaluation of graft patency. J Thorac Dis. 2017 Apr;9(Suppl 4):S283-S288. doi: 10.21037/jtd.2017.03.111.</citation>
    <PMID>28540071</PMID>
  </reference>
  <reference>
    <citation>Barbero U, Iannaccone M, d'Ascenzo F, Barbero C, Mohamed A, Annone U, Benedetto S, Celentani D, Gagliardi M, Moretti C, Gaita F. 64 slice-coronary computed tomography sensitivity and specificity in the evaluation of coronary artery bypass graft stenosis: A meta-analysis. Int J Cardiol. 2016 Aug 1;216:52-7. doi: 10.1016/j.ijcard.2016.04.156. Epub 2016 Apr 22.</citation>
    <PMID>27140337</PMID>
  </reference>
  <reference>
    <citation>TTE/TEE Appropriateness Criteria Writing Group; Douglas PS, Khandheria B, Stainback RF, Weissman NJ; TTE/TEE Appropriateness Criteria Technical Panel; Brindis RG, Patel MR, Alpert JS, Fitzgerald D, Heidenreich P, Martin ET, Messer JV, Miller AB, Picard MH, Raggi P, Reed KD, Rumsfeld JS, Steimle AE, Tonkovic R, Vijayaraghavan K, Yeon SB; ACCF Appropriateness Criteria Working Group; Hendel RC, Peterson E, Wolk MJ, Allen JM; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Echocardiography; American College of Emergency Physicians; American Society of Nuclear Cardiology; Society for Cardiovascular Angiography and Interventions; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance. ACCF/ASE/ACEP/ASNC/SCAI/SCCT/SCMR 2007 appropriateness criteria for transthoracic and transesophageal echocardiography: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American Society of Echocardiography, American College of Emergency Physicians, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance. Endorsed by the American College of Chest Physicians and the Society of Critical Care Medicine. J Am Soc Echocardiogr. 2007 Jul;20(7):787-805. doi: 10.1016/j.echo.2007.06.011. No abstract available.</citation>
    <PMID>17617305</PMID>
  </reference>
  <reference>
    <citation>Goldman S, Zadina K, Krasnicka B, Moritz T, Sethi G, Copeland J, Ovitt T, Henderson W. Predictors of graft patency 3 years after coronary artery bypass graft surgery. Department of Veterans Affairs Cooperative Study Group No. 297. J Am Coll Cardiol. 1997 Jun;29(7):1563-8. doi: 10.1016/s0735-1097(97)82539-9.</citation>
    <PMID>9180120</PMID>
  </reference>
  <reference>
    <citation>Greenland P, Knoll MD, Stamler J, Neaton JD, Dyer AR, Garside DB, Wilson PW. Major risk factors as antecedents of fatal and nonfatal coronary heart disease events. JAMA. 2003 Aug 20;290(7):891-7. doi: 10.1001/jama.290.7.891.</citation>
    <PMID>12928465</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Eman Abdallah Hasaballah Farag</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT03265041
org study id: CT coronary post CABG
nct id: NCT03265041
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To detect and evaluate the predictors of graft patency after coronary artery bypass graft
      surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography
Coronary artery bypass grafting (CABG) is an effective treatment of complex, multi-vessel
      coronary artery disease(1) .The majority of these patients receive left internal mammary
      artery (IMA) grafts to the left anterior descending (LAD) coronary artery and saphenous vein
      grafts (SVGs) or other conduits to the remaining vessels. Based on small studies of selected
      groups of patients, it is generally believed that SVGs have a 40% to 50% 10-year patency and
      that the LIMA has a 90% to 95% 10-year patency The success of coronary artery bypass grafting
      (CABG) is dependent on the long-term patency of the arterial and venous grafts.(2) Graft
      failure is a surrogate marker for future cardiac events, including repeat revascularization,
      myocardial infarction ,and death(3)(4). Vein graft occlusion in the perioperative period is
      due to thrombosis resulting from technical problems. Vein graft occlusion within the first
      year is attributed to intimal proliferation, although after 1 year, atherosclerosis is
      thought to be the dominant factor (5) . LIMA graft failure was defined as diffuse and >95%
      conduit narrowing ("string sign" When IMA graft failure occurs, technical error is the most
      common cause in the early postoperative period, while late (and rare) IMA failure include
      progressive fibro-intimal proliferation and atherosclerosis either in the IMA graft or in the
      native LAD vessel)(6) Traditionally, graft patency has been evaluated with coronary
      angiography (ICA) but, since the advent of multi-detector computed tomography (MDCT), the
      temptation to use a noninvasive and widely available technique to study coronary artery
      bypass graft (CABG) patients has been stronger. The introduction of scanners like 64-slice
      and 128-slice upwards-along with new scan protocols opens new perspectives in non-invasive
      assessment of graft patency.(7) The pooled sensitivity and specificity of detecting complete
      graft occlusions - according to( Barbero et al ,2016) ,was 99% and 99% respectively as
      compared to the standard of coronary angiography. (8) Computed tomographic angiography,
      labeled as Appropriate test for evaluation of bypass grafts and coronary anatomy (9)
observational model: Other
time perspective: Retrospective
measure: detection of predictors of long term graft patency following CABG
time frame: 1 year
description: a. Primary (main): evaluation of long term predictors of graft patency following coronary artery bypass graft surgery
Clinical risk factors e.g Age, gender, smoking, Diabetus mellitus, hypertension, Dyslipidemia, chronic kidney disease, congestive heart failure, medications especially antiplatelet and statin therapy, beta-blockers and calcium channel blockers .
Biochemical risk factors e.g HDL, LDL, Total cholesterol level
Angiographic risk factors : competitive flow and degree of stenosis in the native vessels.
measure: Assessment of re-hospitalization rate following CABG
time frame: 1 year
measure: Relation between type of the graft and graft patency
time frame: 1 year
measure: Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency
time frame: 1 year
intervention type: Diagnostic Test
intervention name: multi-slice CT coronary angiography and coronary angiography
description: multi-slice CT coronary angiography to evaluate graft number and patency validated by coronary angiography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
facility: 
country: Egypt
citation: Harskamp RE, Alexander JH, Ferguson TB, Hager R, Mack MJ, Englum B, et al. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical OutcomesCLINICAL PERSPECTIVE. Circulation [Internet]. 2016;133(2):131-8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26647082%5Cnhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC4814323%5Cnhttp://circ.ahajournals.org/lookup/doi/10.1161/CIRCULATIONAHA.115.015549
citation: Di Lazzaro D, Crusco F. CT angio for the evaluation of graft patency. J Thorac Dis. 2017 Apr;9(Suppl 4):S283-S288. doi: 10.21037/jtd.2017.03.111.
PMID: 28540071
citation: Barbero U, Iannaccone M, d'Ascenzo F, Barbero C, Mohamed A, Annone U, Benedetto S, Celentani D, Gagliardi M, Moretti C, Gaita F. 64 slice-coronary computed tomography sensitivity and specificity in the evaluation of coronary artery bypass graft stenosis: A meta-analysis. Int J Cardiol. 2016 Aug 1;216:52-7. doi: 10.1016/j.ijcard.2016.04.156. Epub 2016 Apr 22.
PMID: 27140337
citation: TTE/TEE Appropriateness Criteria Writing Group; Douglas PS, Khandheria B, Stainback RF, Weissman NJ; TTE/TEE Appropriateness Criteria Technical Panel; Brindis RG, Patel MR, Alpert JS, Fitzgerald D, Heidenreich P, Martin ET, Messer JV, Miller AB, Picard MH, Raggi P, Reed KD, Rumsfeld JS, Steimle AE, Tonkovic R, Vijayaraghavan K, Yeon SB; ACCF Appropriateness Criteria Working Group; Hendel RC, Peterson E, Wolk MJ, Allen JM; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Echocardiography; American College of Emergency Physicians; American Society of Nuclear Cardiology; Society for Cardiovascular Angiography and Interventions; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance. ACCF/ASE/ACEP/ASNC/SCAI/SCCT/SCMR 2007 appropriateness criteria for transthoracic and transesophageal echocardiography: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American Society of Echocardiography, American College of Emergency Physicians, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance. Endorsed by the American College of Chest Physicians and the Society of Critical Care Medicine. J Am Soc Echocardiogr. 2007 Jul;20(7):787-805. doi: 10.1016/j.echo.2007.06.011. No abstract available.
PMID: 17617305
citation: Goldman S, Zadina K, Krasnicka B, Moritz T, Sethi G, Copeland J, Ovitt T, Henderson W. Predictors of graft patency 3 years after coronary artery bypass graft surgery. Department of Veterans Affairs Cooperative Study Group No. 297. J Am Coll Cardiol. 1997 Jun;29(7):1563-8. doi: 10.1016/s0735-1097(97)82539-9.
PMID: 9180120
citation: Greenland P, Knoll MD, Stamler J, Neaton JD, Dyer AR, Garside DB, Wilson PW. Major risk factors as antecedents of fatal and nonfatal coronary heart disease events. JAMA. 2003 Aug 20;290(7):891-7. doi: 10.1001/jama.290.7.891.
PMID: 12928465
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Eman Abdallah Hasaballah Farag
investigator title: resident
mesh term: Coronary Artery Disease