<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/NCT03269838</url>
  </required_header>
  <id_info>
    <org_study_id>17100310</org_study_id>
    <nct_id>NCT03269838</nct_id>
  </id_info>
  <brief_title>Correlation of QT Dispersion With Myocardial Perfusion in Patients With ST Elevation Myocardial Infarction Treated by Primary Per Cutaneous Coronary Intervention</brief_title>
  <official_title>Correlation of QT Dispersion With Myocardial Perfusion in Patients With ST Elevation Myocardial Infarction Treated by Primary Per Cutaneous Coronary Intervention</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 correlate QT dispersion on 12-lead surface ECG with myocardial reperfusion evaluated by&#xD;
      myocardial blush grade and Thrombolysis in myocardial infarction (TIMI) flow grades in&#xD;
      patients with ST elevation myocardial infarction treated by Primary Per cutaneous coronary&#xD;
      intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide, coronary artery disease (CAD) is the most frequent cause of death. Over seven&#xD;
      million people every year die from CAD, accounting for 12.8% of all deaths. Every sixth man&#xD;
      and every seventh woman in Europe die from myocardial infarction. The in-hospital mortality&#xD;
      of STEMI patients in the national registries of the European society of cardiology (ESC)&#xD;
      countries varies between 6% and 14%.&#xD;
&#xD;
      ST elevation myocardial infarction (STEMI) generally results from intraluminal thrombus&#xD;
      formation and occlusion of a ruptured or an unstable plaque .&#xD;
&#xD;
      The main goal of therapy in STEMI is to restore microvascular flow and sustain the myocardial&#xD;
      perfusion .&#xD;
&#xD;
      Reperfusion therapy for acute myocardial infarction (AMI) is aimed at achieving prompt&#xD;
      restoration of myocardial perfusion to maximize preservation of the electrical and mechanical&#xD;
      integrity of the jeopardized myocardium. Percutaneous coronary intervention (PCI) has&#xD;
      increased the rate of successful recanalization of infarct-related arteries (IRAs) to &gt;90% .&#xD;
&#xD;
      A variety of markers including ECG and coronary angiography have been utilized to assess&#xD;
      myocardial reperfusion .&#xD;
&#xD;
      The prolongation of QRS duration,evaluated by a standard 12-lead ECG, is a marker of&#xD;
      ventricular dysfunction and has been associated with a poor prognosis in STEMI .&#xD;
&#xD;
      QT-interval parameters are potentially proposed as available non-invasive markers for&#xD;
      assessing the ventricular homogeneity as well as for predicting electrical instability ,QT&#xD;
      interval (QTI) is defined as the longest interval from the beginning of the QRS complex to&#xD;
      the end of the T-wave; QT dispersion (QTd) is defined as the difference between the longest&#xD;
      and shortest QTI, and reflects electrical activity of the ventricles . .&#xD;
&#xD;
      The prolongation of the latter parameter is a main predictor for fatal arrhythmia in patients&#xD;
      with myocardial infarction (MI) .&#xD;
&#xD;
      The measurement of QTI and QTd parameters are dependent on heart rate and can be corrected by&#xD;
      the QT correction formulas, which are termed the corrected QTI (QTc) and QTd (QTcd) .&#xD;
&#xD;
      Myocardial blush grade (MBG) is validated measurement of myocardial perfusion . The MBG is&#xD;
      used to assess the washout of myocardial blush during angiography. Grade 0 is defined as the&#xD;
      failure of the contrast to enter the microvasculature. In grade 1 cases, contrast enters&#xD;
      slowly, but fails to exit the microvasculature. Grade 2 defines delayed entry and exit from&#xD;
      the microvasculature. Finally, grade 3 indicates normal entry and exit from the&#xD;
      microvasculature .&#xD;
&#xD;
      ECG is a necessary, simple, rapid and non invasive tool for the diagnosis of myocardial&#xD;
      infarction and evaluation of myocardial reperfusion that still to be investigated . QT&#xD;
      dispersion is a crude and approximate measure of a general abnormality of repolarization; it&#xD;
      reflects inhomogeneity of ventricular repolarization . This measurement is an attempt to&#xD;
      distinguish between myocardium that is homogeneous from myocardium that displays&#xD;
      inhomogeneity, which is accompanied by increased dispersion of the ventricular recovery times&#xD;
      and prolongation of repolarization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of QT dispersion on 12-lead surface ECG with myocardial reperfusion</measure>
    <time_frame>1 year</time_frame>
    <description>Use 12 lead ECG to calculate QT interval and QT dispersion comparing ECG before and after myocardial reperfusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of myocardial perfusion by coronary angiography by assessing 2 parameters TIMI flow and myocardial blush grade</measure>
    <time_frame>1 year</time_frame>
    <description>Use coronary angiography to detect myocardial blush grade and TIMI flow to assess myocardial reperfusion</description>
  </primary_outcome>
  <enrollment type="Anticipated">235</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ECG</intervention_name>
    <description>Primary Percutaneous coronary intervention</description>
    <other_name>Primary Percutaneous coronary intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This cross sectional observational study will include patients with acute STEMI of&#xD;
        different ages from cardiology department, Assiut University Hospital who will undergo&#xD;
        primary percutaneous coronary intervention (PCI).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be enrolled in this study if they fulfilled the criteria of acute ST&#xD;
             elevation myocardial infarction eligible to be treated with primary Percutaneous&#xD;
             coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-ST elevation myocardial infarction, prior history of myocardial infarction or&#xD;
             surgical revascularization,&#xD;
&#xD;
          2. Electrolyte disturbance.&#xD;
&#xD;
          3. history of medications that may affect QT (anti-arrhythmic, anti-psychotic, and&#xD;
             anti-depressant drugs),&#xD;
&#xD;
          4. patients with cardiogenic shock or needing IABP.&#xD;
&#xD;
          5. patients with previous CABG.&#xD;
&#xD;
          6. Patients with implantable devices and pacemakers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hatem Helmy</last_name>
    <role>Study Chair</role>
    <affiliation>assistant professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Hasan</last_name>
    <role>Study Chair</role>
    <affiliation>professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina Samir, master</last_name>
    <phone>01204836349</phone>
    <email>morajesus24@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71641</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Samir, master</last_name>
      <phone>01204836349</phone>
      <email>morajesus24@outlook.com</email>
    </contact>
    <investigator>
      <last_name>Hossam El-Araby</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hatem Helmy</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marina Samir</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Karahan Z, Yaylak B, Ugurlu M, Kaya I, Ucaman B, Ozturk O. QRS duration: a novel marker of microvascular reperfusion as assessed by myocardial blush grade in ST elevation myocardial infarction patients undergoing a primary percutaneous intervention. Coron Artery Dis. 2015 Nov;26(7):583-6. doi: 10.1097/MCA.0000000000000285.</citation>
    <PMID>26166018</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>June 30, 2018</last_update_submitted>
  <last_update_submitted_qc>June 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>MS Roshdy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03269838
org study id: 17100310
nct id: NCT03269838
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To correlate QT dispersion on 12-lead surface ECG with myocardial reperfusion evaluated by
      myocardial blush grade and Thrombolysis in myocardial infarction (TIMI) flow grades in
      patients with ST elevation myocardial infarction treated by Primary Per cutaneous coronary
      intervention
Worldwide, coronary artery disease (CAD) is the most frequent cause of death. Over seven
      million people every year die from CAD, accounting for 12.8% of all deaths. Every sixth man
      and every seventh woman in Europe die from myocardial infarction. The in-hospital mortality
      of STEMI patients in the national registries of the European society of cardiology (ESC)
      countries varies between 6% and 14%.

      ST elevation myocardial infarction (STEMI) generally results from intraluminal thrombus
      formation and occlusion of a ruptured or an unstable plaque .

      The main goal of therapy in STEMI is to restore microvascular flow and sustain the myocardial
      perfusion .

      Reperfusion therapy for acute myocardial infarction (AMI) is aimed at achieving prompt
      restoration of myocardial perfusion to maximize preservation of the electrical and mechanical
      integrity of the jeopardized myocardium. Percutaneous coronary intervention (PCI) has
      increased the rate of successful recanalization of infarct-related arteries (IRAs) to >90% .

      A variety of markers including ECG and coronary angiography have been utilized to assess
      myocardial reperfusion .

      The prolongation of QRS duration,evaluated by a standard 12-lead ECG, is a marker of
      ventricular dysfunction and has been associated with a poor prognosis in STEMI .

      QT-interval parameters are potentially proposed as available non-invasive markers for
      assessing the ventricular homogeneity as well as for predicting electrical instability ,QT
      interval (QTI) is defined as the longest interval from the beginning of the QRS complex to
      the end of the T-wave; QT dispersion (QTd) is defined as the difference between the longest
      and shortest QTI, and reflects electrical activity of the ventricles . .

      The prolongation of the latter parameter is a main predictor for fatal arrhythmia in patients
      with myocardial infarction (MI) .

      The measurement of QTI and QTd parameters are dependent on heart rate and can be corrected by
      the QT correction formulas, which are termed the corrected QTI (QTc) and QTd (QTcd) .

      Myocardial blush grade (MBG) is validated measurement of myocardial perfusion . The MBG is
      used to assess the washout of myocardial blush during angiography. Grade 0 is defined as the
      failure of the contrast to enter the microvasculature. In grade 1 cases, contrast enters
      slowly, but fails to exit the microvasculature. Grade 2 defines delayed entry and exit from
      the microvasculature. Finally, grade 3 indicates normal entry and exit from the
      microvasculature .

      ECG is a necessary, simple, rapid and non invasive tool for the diagnosis of myocardial
      infarction and evaluation of myocardial reperfusion that still to be investigated . QT
      dispersion is a crude and approximate measure of a general abnormality of repolarization; it
      reflects inhomogeneity of ventricular repolarization . This measurement is an attempt to
      distinguish between myocardium that is homogeneous from myocardium that displays
      inhomogeneity, which is accompanied by increased dispersion of the ventricular recovery times
      and prolongation of repolarization
observational model: Cohort
time perspective: Cross-Sectional
measure: Correlation of QT dispersion on 12-lead surface ECG with myocardial reperfusion
time frame: 1 year
description: Use 12 lead ECG to calculate QT interval and QT dispersion comparing ECG before and after myocardial reperfusion.
measure: Evaluation of myocardial perfusion by coronary angiography by assessing 2 parameters TIMI flow and myocardial blush grade
time frame: 1 year
description: Use coronary angiography to detect myocardial blush grade and TIMI flow to assess myocardial reperfusion
intervention type: Diagnostic Test
intervention name: ECG
description: Primary Percutaneous coronary intervention
other name: Primary Percutaneous coronary intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Hatem Helmy
role: Study Chair
affiliation: assistant professor
last name: Hosam Hasan
role: Study Chair
affiliation: professor
last name: Marina Samir, master
phone: 01204836349
email: morajesus24@outlook.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: Karahan Z, Yaylak B, Ugurlu M, Kaya I, Ucaman B, Ozturk O. QRS duration: a novel marker of microvascular reperfusion as assessed by myocardial blush grade in ST elevation myocardial infarction patients undergoing a primary percutaneous intervention. Coron Artery Dis. 2015 Nov;26(7):583-6. doi: 10.1097/MCA.0000000000000285.
PMID: 26166018
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: MS Roshdy
investigator title: Principal Investigator
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction