<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/NCT03266978</url>
  </required_header>
  <id_info>
    <org_study_id>ODMI Assiut</org_study_id>
    <nct_id>NCT03266978</nct_id>
  </id_info>
  <brief_title>Impact of Glycemic State on Patients ST Elevation Myocardial Infarction With Primary Percutaneous Coronary Angioplasty</brief_title>
  <official_title>Impact of the Glycemic State on the in Hospital and Short Term Outcomes of Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Angioplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide.&#xD;
      ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia&#xD;
      and necrosis, resulting in impairment of both systolic and diastolic functions of the heart.&#xD;
      Left ventricular function and myocardial infarct size both serve as the main determinants Of&#xD;
      patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial&#xD;
      infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous&#xD;
      coronary intervention, leads to a better outcome for these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reperfusion failure is attributed to different factors, including diabetes. Several&#xD;
      mechanisms have been proposed for the harmful effects of hyperglycemia after acute myocardial&#xD;
      infarction. Association of hyperglycemia with the activation of blood coagulation has been&#xD;
      well studied; it could induce a shortening of the fibrinogen half-life, increase in&#xD;
      fibrinopeptide A, fragments of pro-thrombin in factor VII, and platelet aggregation, all of&#xD;
      which could lead to increased activation of thrombosis. Hyperglycemia at admission is&#xD;
      associated with increased levels of inflammatory markers, enhanced expression of cytotoxic&#xD;
      T-cells, and reduced expression of cytotoxic T-lymphocyte-associated protein 4, indicating&#xD;
      its association with increased inflammatory immune process after acute myocardial infarction.&#xD;
      It also could be associated with endothelial dysfunction, oxidative stress, and possibly,&#xD;
      abolition of protective ischemic preconditioning. Other possible mechanism of harmful effects&#xD;
      of acute hyperglycemia is microvascular dysfunction after coronary revascularization.&#xD;
&#xD;
      Studying the influence of diabetes mellitus on clinical outcome in the thrombolytic era of&#xD;
      acute myocardial infarction, GUSTO-I trial showed that patients with diabetes mellitus have a&#xD;
      significantly increased risk of both early and late mortality, which may be attributed to&#xD;
      more advanced coronary artery disease and co-morbidities.&#xD;
&#xD;
      Results of the HORIZONS-AMI study showed that patients with newly diagnosed diabetes mellitus&#xD;
      had similarly poor prognosis after primary percutaneous coronary intervention in ST-elevation&#xD;
      myocardial infarction patients as those with previously established diabetes mellitus, newly&#xD;
      diagnosed diabetes mellitus was based on HgbA1c levels following admission and did not assess&#xD;
      for blood glucose levels at admission or during hospital stay.&#xD;
&#xD;
      Regarding the effect of diabetes mellitus on left ventricular systolic function, diabetic&#xD;
      patients with first ST-elevation myocardial infarction had reduced left ventricular systolic&#xD;
      function, measured with speckle-tracking strain, compared with non-diabetic patients at&#xD;
      baseline and at 6-month follow up, despite similar left ventricular ejection fraction in both&#xD;
      groups. Similarly, according to the ischemic cascade, diastolic function is expected to be&#xD;
      affected with variable degrees among diabetic, prediabetic and non-diabetic ST-elevation&#xD;
      myocardial infarction patients.&#xD;
&#xD;
      Timmer et al, studied the effect of admission stress hyperglycemia and that of chronic&#xD;
      hyperglycemia (elevated levels of HbA1c in patients with undiagnosed diabetes mellitus) on&#xD;
      ST-elevation myocardial infarction patients undergoing primary percutaneous coronary&#xD;
      intervention; both elevated glucose and HbA1c levels were associated with adverse outcomes.&#xD;
      However elevated glucose but not elevated HbA1c was associated with larger enzymatic infarct&#xD;
      size and high early mortality.&#xD;
&#xD;
      Furthermore, Ota et al, demonstrated the association between stress hyperglycemia and the&#xD;
      development of microvascular obstruction using late gadolinium enhancement - cardiovascular&#xD;
      magnetic resonance imaging, suggesting that hyperglycemic control immediately after admission&#xD;
      might reduce the incidence of microvascular obstruction.&#xD;
&#xD;
      This study is designed to explore the impact of the glycemic state on the in-hospital and&#xD;
      short term outcomes of patients with ST-elevation myocardial infarction undergoing&#xD;
      reperfusion therapy in two separate arms; those with known diabetes mellitus and those&#xD;
      without known diagnosis of diabetes mellitus, and then comparing results among those with&#xD;
      controlled diabetes mellitus, uncontrolled diabetes mellitus and newly diagnosed diabetes&#xD;
      mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Admission glucose level</measure>
    <time_frame>Baseline .</time_frame>
    <description>Blood glucose level on admission measured by mmol/l .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate left ventricular systolic function.</measure>
    <time_frame>Baseline and latter at 6 months follow-up.</time_frame>
    <description>Using transthoracic echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate left ventricular diastolic function.</measure>
    <time_frame>Baseline and latter at 6 months follow-up.</time_frame>
    <description>Using transthoracic echocardiography.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting to investigators Coronary Care Unit - Assiut University Heart&#xD;
        Center with acute ST-elevation myocardial infarction undergoing primary percutaneous&#xD;
        coronary intervention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will be performed on acute ST-elevation myocardial infarction patients&#xD;
             with/without history of diabetes mellitus undergoing primary percutaneous coronary&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not treated with primary percutaneous coronary intervention.&#xD;
&#xD;
          -  Patients with prior myocardial infarction, prior primary percutaneous coronary&#xD;
             intervention and/or coronary artery bypass graft (altering disease state).&#xD;
&#xD;
          -  Patients with cardiogenic shock (altering disease state).&#xD;
&#xD;
          -  Patients with severe liver or renal disease (altering disease state).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amr Youssef, MD</last_name>
    <phone>00201006554042</phone>
    <email>amryoussef111@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mahmoud Abd Allah, MD</last_name>
    <phone>00201001202779</phone>
    <email>m_abd_elsabour@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Heba Elnaggar, MD</last_name>
      <phone>01001963100</phone>
      <email>heba_m_elnaggar@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Ertelt K, Brener SJ, Mehran R, Ben-Yehuda O, McAndrew T, Stone GW. Comparison of Outcomes and Prognosis of Patients With Versus Without Newly Diagnosed Diabetes Mellitus After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (the HORIZONS-AMI Study). Am J Cardiol. 2017 Jun 15;119(12):1917-1923. doi: 10.1016/j.amjcard.2017.03.016. Epub 2017 Mar 29.</citation>
    <PMID>28427734</PMID>
  </results_reference>
  <results_reference>
    <citation>Ota S, Tanimoto T, Orii M, Hirata K, Shiono Y, Shimamura K, Matsuo Y, Yamano T, Ino Y, Kitabata H, Yamaguchi T, Kubo T, Tanaka A, Imanishi T, Akasaka T. Association between hyperglycemia at admission and microvascular obstruction in patients with ST-segment elevation myocardial infarction. J Cardiol. 2015 Apr;65(4):272-7. doi: 10.1016/j.jjcc.2014.10.013. Epub 2014 Dec 19.</citation>
    <PMID>25533423</PMID>
  </results_reference>
  <results_reference>
    <citation>Iwakura K. Stress hyperglycemia and microvascular obstruction after acute myocardial infarction. J Cardiol. 2015 Apr;65(4):270-1. doi: 10.1016/j.jjcc.2014.11.012. Epub 2014 Dec 29. No abstract available.</citation>
    <PMID>25553870</PMID>
  </results_reference>
  <results_reference>
    <citation>Marfella R, Siniscalchi M, Esposito K, Sellitto A, De Fanis U, Romano C, Portoghese M, Siciliano S, Nappo F, Sasso FC, Mininni N, Cacciapuoti F, Lucivero G, Giunta R, Verza M, Giugliano D. Effects of stress hyperglycemia on acute myocardial infarction: role of inflammatory immune process in functional cardiac outcome. Diabetes Care. 2003 Nov;26(11):3129-35. doi: 10.2337/diacare.26.11.3129.</citation>
    <PMID>14578250</PMID>
  </results_reference>
  <results_reference>
    <citation>Sattur S, Sarwar B, Sacchi TJ, Brener SJ. Correlation between markers of reperfusion and mortality in ST-elevation myocardial infarction: a systematic review. J Invasive Cardiol. 2014 Nov;26(11):587-95.</citation>
    <PMID>25364000</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>El shaimaa Abd El Fattah Omran</investigator_full_name>
    <investigator_title>pricipal investgator</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>
  <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/NCT03266978
org study id: ODMI Assiut
nct id: NCT03266978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide.
      ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia
      and necrosis, resulting in impairment of both systolic and diastolic functions of the heart.
      Left ventricular function and myocardial infarct size both serve as the main determinants Of
      patients' outcome after myocardial infarction. Timely management of ST-elevation myocardial
      infarction, using reperfusion therapy, including fibrinolysis and primary percutaneous
      coronary intervention, leads to a better outcome for these patients.
Reperfusion failure is attributed to different factors, including diabetes. Several
      mechanisms have been proposed for the harmful effects of hyperglycemia after acute myocardial
      infarction. Association of hyperglycemia with the activation of blood coagulation has been
      well studied; it could induce a shortening of the fibrinogen half-life, increase in
      fibrinopeptide A, fragments of pro-thrombin in factor VII, and platelet aggregation, all of
      which could lead to increased activation of thrombosis. Hyperglycemia at admission is
      associated with increased levels of inflammatory markers, enhanced expression of cytotoxic
      T-cells, and reduced expression of cytotoxic T-lymphocyte-associated protein 4, indicating
      its association with increased inflammatory immune process after acute myocardial infarction.
      It also could be associated with endothelial dysfunction, oxidative stress, and possibly,
      abolition of protective ischemic preconditioning. Other possible mechanism of harmful effects
      of acute hyperglycemia is microvascular dysfunction after coronary revascularization.

      Studying the influence of diabetes mellitus on clinical outcome in the thrombolytic era of
      acute myocardial infarction, GUSTO-I trial showed that patients with diabetes mellitus have a
      significantly increased risk of both early and late mortality, which may be attributed to
      more advanced coronary artery disease and co-morbidities.

      Results of the HORIZONS-AMI study showed that patients with newly diagnosed diabetes mellitus
      had similarly poor prognosis after primary percutaneous coronary intervention in ST-elevation
      myocardial infarction patients as those with previously established diabetes mellitus, newly
      diagnosed diabetes mellitus was based on HgbA1c levels following admission and did not assess
      for blood glucose levels at admission or during hospital stay.

      Regarding the effect of diabetes mellitus on left ventricular systolic function, diabetic
      patients with first ST-elevation myocardial infarction had reduced left ventricular systolic
      function, measured with speckle-tracking strain, compared with non-diabetic patients at
      baseline and at 6-month follow up, despite similar left ventricular ejection fraction in both
      groups. Similarly, according to the ischemic cascade, diastolic function is expected to be
      affected with variable degrees among diabetic, prediabetic and non-diabetic ST-elevation
      myocardial infarction patients.

      Timmer et al, studied the effect of admission stress hyperglycemia and that of chronic
      hyperglycemia (elevated levels of HbA1c in patients with undiagnosed diabetes mellitus) on
      ST-elevation myocardial infarction patients undergoing primary percutaneous coronary
      intervention; both elevated glucose and HbA1c levels were associated with adverse outcomes.
      However elevated glucose but not elevated HbA1c was associated with larger enzymatic infarct
      size and high early mortality.

      Furthermore, Ota et al, demonstrated the association between stress hyperglycemia and the
      development of microvascular obstruction using late gadolinium enhancement - cardiovascular
      magnetic resonance imaging, suggesting that hyperglycemic control immediately after admission
      might reduce the incidence of microvascular obstruction.

      This study is designed to explore the impact of the glycemic state on the in-hospital and
      short term outcomes of patients with ST-elevation myocardial infarction undergoing
      reperfusion therapy in two separate arms; those with known diabetes mellitus and those
      without known diagnosis of diabetes mellitus, and then comparing results among those with
      controlled diabetes mellitus, uncontrolled diabetes mellitus and newly diagnosed diabetes
      mellitus.
observational model: Cohort
time perspective: Prospective
measure: Admission glucose level
time frame: Baseline .
description: Blood glucose level on admission measured by mmol/l .
measure: To evaluate left ventricular systolic function.
time frame: Baseline and latter at 6 months follow-up.
description: Using transthoracic echocardiography.
measure: To evaluate left ventricular diastolic function.
time frame: Baseline and latter at 6 months follow-up.
description: Using transthoracic echocardiography.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amr Youssef, MD
phone: 00201006554042
email: amryoussef111@yahoo.com
last name: Mahmoud Abd Allah, MD
phone: 00201001202779
email: m_abd_elsabour@yahoo.com
facility: 
contact: 
country: Egypt
citation: Ertelt K, Brener SJ, Mehran R, Ben-Yehuda O, McAndrew T, Stone GW. Comparison of Outcomes and Prognosis of Patients With Versus Without Newly Diagnosed Diabetes Mellitus After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (the HORIZONS-AMI Study). Am J Cardiol. 2017 Jun 15;119(12):1917-1923. doi: 10.1016/j.amjcard.2017.03.016. Epub 2017 Mar 29.
PMID: 28427734
citation: Ota S, Tanimoto T, Orii M, Hirata K, Shiono Y, Shimamura K, Matsuo Y, Yamano T, Ino Y, Kitabata H, Yamaguchi T, Kubo T, Tanaka A, Imanishi T, Akasaka T. Association between hyperglycemia at admission and microvascular obstruction in patients with ST-segment elevation myocardial infarction. J Cardiol. 2015 Apr;65(4):272-7. doi: 10.1016/j.jjcc.2014.10.013. Epub 2014 Dec 19.
PMID: 25533423
citation: Iwakura K. Stress hyperglycemia and microvascular obstruction after acute myocardial infarction. J Cardiol. 2015 Apr;65(4):270-1. doi: 10.1016/j.jjcc.2014.11.012. Epub 2014 Dec 29. No abstract available.
PMID: 25553870
citation: Marfella R, Siniscalchi M, Esposito K, Sellitto A, De Fanis U, Romano C, Portoghese M, Siciliano S, Nappo F, Sasso FC, Mininni N, Cacciapuoti F, Lucivero G, Giunta R, Verza M, Giugliano D. Effects of stress hyperglycemia on acute myocardial infarction: role of inflammatory immune process in functional cardiac outcome. Diabetes Care. 2003 Nov;26(11):3129-35. doi: 10.2337/diacare.26.11.3129.
PMID: 14578250
citation: Sattur S, Sarwar B, Sacchi TJ, Brener SJ. Correlation between markers of reperfusion and mortality in ST-elevation myocardial infarction: a systematic review. J Invasive Cardiol. 2014 Nov;26(11):587-95.
PMID: 25364000
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: El shaimaa Abd El Fattah Omran
investigator title: pricipal investgator
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided