<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/NCT03829605</url>
  </required_header>
  <id_info>
    <org_study_id>Myocardial infarction</org_study_id>
    <nct_id>NCT03829605</nct_id>
  </id_info>
  <brief_title>Plasma Hydrogen Sulfide, Nitric Oxide and Stress Hyperglycemia in Acute Myocardial Infarction</brief_title>
  <official_title>Plasma Measurement of Hydrogen Sulfide, Nitric Oxide and Stress Hyperglycemia in Acute Myocardial Infarction</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>
      Acute myocardial infarction (AMI) can cause heart failure, an irregular heartbeat,&#xD;
      cardiogenic shock, or cardiac arrest. It is the major cause of morbidity and mortality in the&#xD;
      general population. The diagnosis of AMI is complex basing on the clinical history, physical&#xD;
      examination, cardiac markers, and a chest radiograph. Besides, considering that the&#xD;
      mechanisms linking activation of inflammation and ACS are complex as well, progress in&#xD;
      diagnosis and therapy improves little&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization (WHO) indexed cardiovascular disease (CVD) as a leading&#xD;
      foundation for human death in developing as well as developed countries. Ischemic necrosis of&#xD;
      the myocardium is called myocar¬dial infarction. Despite improvements in medical and&#xD;
      interventional therapies in recent years, acute myocar¬dial infarction is still an important&#xD;
      cause of mortal¬ity and morbidity. Hydrogen sulfide (H2S) is a colorless, water-soluble gas&#xD;
      and is an endogenously produced labile diffusible mediator with multiple roles in the&#xD;
      cardiovascular system in health and disease. H2S is endogenously generated, and&#xD;
      cystathionine-β-synthase (CBS), cystathionine-γ-lyase (CSE), and 3-mercaptopyruvate&#xD;
      sulfurtransferase (3-MST) are key enzymes involved in its biological production. Once&#xD;
      interacting with carbon monoxide and nitric oxide, H2S will initiate a unique gaseous&#xD;
      signaling net¬work and participate in the regulation of multiple patho¬physiological&#xD;
      processes. Plasma H2S levels negatively correlated with HbA1c, duration of diabetes, and&#xD;
      systolic and diastolic blood pressures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">May 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 20, 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>The mean difference of hydrogen sulfide before and after treatment</measure>
    <time_frame>12 hours</time_frame>
    <description>Hydrogen sulfide mean difference will be measured by ELISA in myocardial infarction.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Group I:</arm_group_label>
    <description>Fifty AMI patients on admission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II:</arm_group_label>
    <description>The previous AMI patients after 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of hydrogen sulfide</intervention_name>
    <description>Hydrogen sulfide will be measured by ELISA and correlated with nitric oxide and hyperglycemia</description>
    <arm_group_label>Group I:</arm_group_label>
    <arm_group_label>Group II:</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute myocardial infarction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed diagnosis of AMI-&#xD;
&#xD;
          -  Patients of age 18 years or more who are willing to participate in the study and give&#xD;
             their consent for same.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with congenital heart diseases, alcoholics with a past history of liver&#xD;
             disease, pulmonary embolus, sepsis, chest trauma, and renal failure were excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>reham elmahdy, Dr</last_name>
    <phone>+201002714637</phone>
    <email>reham.elmahdy@aun.edu.eg</email>
  </overall_contact>
  <reference>
    <citation>Suzuki K, Sagara M, Aoki C, Tanaka S, Aso Y. Clinical Implication of Plasma Hydrogen Sulfide Levels in Japanese Patients with Type 2 Diabetes. Intern Med. 2017;56(1):17-21. doi: 10.2169/internalmedicine.56.7403. Epub 2017 Jan 1.</citation>
    <PMID>28049995</PMID>
  </reference>
  <reference>
    <citation>Peter EA, Shen X, Shah SH, Pardue S, Glawe JD, Zhang WW, Reddy P, Akkus NI, Varma J, Kevil CG. Plasma free H2S levels are elevated in patients with cardiovascular disease. J Am Heart Assoc. 2013 Oct 23;2(5):e000387. doi: 10.1161/JAHA.113.000387.</citation>
    <PMID>24152982</PMID>
  </reference>
  <reference>
    <citation>Kuang Q, Xue N, Chen J, Shen Z, Cui X, Fang Y, Ding X. Low Plasma Hydrogen Sulfide Is Associated with Impaired Renal Function and Cardiac Dysfunction. Am J Nephrol. 2018;47(5):361-371. doi: 10.1159/000489606. Epub 2018 May 18.</citation>
    <PMID>29779029</PMID>
  </reference>
  <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>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Reham I El-mahdy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hydrogen sulfide</keyword>
  <keyword>Nitric oxide</keyword>
  <keyword>Stress hyperglycemia</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrogen Sulfide</mesh_term>
  </intervention_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/NCT03829605
org study id: Myocardial infarction
nct id: NCT03829605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute myocardial infarction (AMI) can cause heart failure, an irregular heartbeat,
      cardiogenic shock, or cardiac arrest. It is the major cause of morbidity and mortality in the
      general population. The diagnosis of AMI is complex basing on the clinical history, physical
      examination, cardiac markers, and a chest radiograph. Besides, considering that the
      mechanisms linking activation of inflammation and ACS are complex as well, progress in
      diagnosis and therapy improves little
The World Health Organization (WHO) indexed cardiovascular disease (CVD) as a leading
      foundation for human death in developing as well as developed countries. Ischemic necrosis of
      the myocardium is called myocar¬dial infarction. Despite improvements in medical and
      interventional therapies in recent years, acute myocar¬dial infarction is still an important
      cause of mortal¬ity and morbidity. Hydrogen sulfide (H2S) is a colorless, water-soluble gas
      and is an endogenously produced labile diffusible mediator with multiple roles in the
      cardiovascular system in health and disease. H2S is endogenously generated, and
      cystathionine-β-synthase (CBS), cystathionine-γ-lyase (CSE), and 3-mercaptopyruvate
      sulfurtransferase (3-MST) are key enzymes involved in its biological production. Once
      interacting with carbon monoxide and nitric oxide, H2S will initiate a unique gaseous
      signaling net¬work and participate in the regulation of multiple patho¬physiological
      processes. Plasma H2S levels negatively correlated with HbA1c, duration of diabetes, and
      systolic and diastolic blood pressures.
observational model: Cohort
time perspective: Prospective
measure: The mean difference of hydrogen sulfide before and after treatment
time frame: 12 hours
description: Hydrogen sulfide mean difference will be measured by ELISA in myocardial infarction.
arm group label: Group I:
description: Fifty AMI patients on admission
arm group label: Group II:
description: The previous AMI patients after 12 hours
intervention type: Other
intervention name: Measurement of hydrogen sulfide
description: Hydrogen sulfide will be measured by ELISA and correlated with nitric oxide and hyperglycemia
arm group label: Group I:
arm group label: Group II:
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: reham elmahdy, Dr
phone: +201002714637
email: reham.elmahdy@aun.edu.eg
citation: Suzuki K, Sagara M, Aoki C, Tanaka S, Aso Y. Clinical Implication of Plasma Hydrogen Sulfide Levels in Japanese Patients with Type 2 Diabetes. Intern Med. 2017;56(1):17-21. doi: 10.2169/internalmedicine.56.7403. Epub 2017 Jan 1.
PMID: 28049995
citation: Peter EA, Shen X, Shah SH, Pardue S, Glawe JD, Zhang WW, Reddy P, Akkus NI, Varma J, Kevil CG. Plasma free H2S levels are elevated in patients with cardiovascular disease. J Am Heart Assoc. 2013 Oct 23;2(5):e000387. doi: 10.1161/JAHA.113.000387.
PMID: 24152982
citation: Kuang Q, Xue N, Chen J, Shen Z, Cui X, Fang Y, Ding X. Low Plasma Hydrogen Sulfide Is Associated with Impaired Renal Function and Cardiac Dysfunction. Am J Nephrol. 2018;47(5):361-371. doi: 10.1159/000489606. Epub 2018 May 18.
PMID: 29779029
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
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Reham I El-mahdy
investigator title: Principal Investigator
mesh term: Myocardial Infarction
mesh term: Hyperglycemia
mesh term: Infarction
mesh term: Hydrogen Sulfide