<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/NCT03830138</url>
  </required_header>
  <id_info>
    <org_study_id>Acute coronary syndrome</org_study_id>
    <nct_id>NCT03830138</nct_id>
  </id_info>
  <brief_title>Oxidized LDL With Oxygen Therapy in Acute Coronary Syndrome.</brief_title>
  <official_title>Oxidized LDL, Oxidized LDL Receptor 1 (OLR1) Gene Polymorphism With Oxygen Therapy 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>
      Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a&#xD;
      younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor&#xD;
      for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk&#xD;
      factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of&#xD;
      the present study was to examine the role of ox-LDL as a risk factor for the presence and&#xD;
      clinical outcomes in patients with MI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease, which is multifactorial and caused by complex interactions of genetic&#xD;
      and environmental factors, represents the main cause of death all over the world. Traditional&#xD;
      risk factors for coronary atherosclerosis include age, smoking, male gender, hypertension and&#xD;
      diabetes. Newly defined risk factors such as hyper-homocysteine, elevated plasma levels of&#xD;
      OxLDL and oxidative stress are also emerging.&#xD;
&#xD;
      Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor of&#xD;
      oxidized low-density lipoproteins which regulates the growth of a variety of cells and is&#xD;
      important in inflammation, atherosclerosis, oxidative stress, and tissue remodeling. LOX-1 is&#xD;
      expressed in various cells, including endothelial cells, macrophages, and chondrocytes, and&#xD;
      its expression is enhanced by proinflammatory cytokines. The LOX1 gene, also known as OLR1,&#xD;
      is located on the chromosome 12p13.1-p12.3. The LOX1 protein is synthesized as a 40-kDa&#xD;
      precursor protein and is composed of four domains: an extracellular lectin-like domain at the&#xD;
      C-terminal, a connecting neck domain, a transmembrane domain, and an N-terminal cytoplasmic&#xD;
      domain. Three single nucleotide polymorphism (SNPs), namely, intron 4 (G→A), intron 5(T→G),&#xD;
      and 3' UTR (T→C) in the LOX1 gene, have been previously reported. These polymorphisms have&#xD;
      also been associated with CAD.&#xD;
&#xD;
      Oxygen is a lifesaving drug. Giving oxygen to a patient with an impending clinical emergency&#xD;
      has become knee-jerk reflex reaction of the clinician. Patient with AMI has compromised&#xD;
      myocardial perfusion and event arises due to myocardial hypoxia. It appears quite logical and&#xD;
      biologically plausible to give oxygen in such situations to improve the oxygenation of the&#xD;
      ischemic myocardial tissue and decrease ischemic pain. On the other side, oxygen may be&#xD;
      harmful with a mechanism such as the paradoxical effect of oxygen in decreasing coronary&#xD;
      artery blood flow and increasing coronary vascular resistance due to increased oxygen free&#xD;
      radicals. The investigators aimed to examine the association of the OLR1 gene with AMI or CAD&#xD;
      in a novel, well-phenotyped, and homogenous, population and its correlation with oxygen&#xD;
      therapy in these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The mean difference of oxidized-LDL gene polymorphism between patients and controls</measure>
    <time_frame>Baseline</time_frame>
    <description>The mean difference of oxidized-LDL gene polymorphism will be assessed by RFLP. The change of single nucleotide polymorphism of oxidized-LDL from healthy controls at baseline</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Acute coronary syndrome patients:</arm_group_label>
    <description>One hundred patients with acute coronary syndrome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls:</arm_group_label>
    <description>Fifty healthy control</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Oxidized-LDL gene polymorphism</intervention_name>
    <description>Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA</description>
    <arm_group_label>Acute coronary syndrome patients:</arm_group_label>
    <arm_group_label>Controls:</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute coronary syndrome patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were included irrespective of concomitant risk factors for atherosclerosis&#xD;
             such as smoking, arterial hypertension and diabetes mellitus.&#xD;
&#xD;
          -  Participants were both sexes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital heart disease.&#xD;
&#xD;
          -  Dilated, hypertrophic or restrictive cardiomyopathy.&#xD;
&#xD;
          -  acute and chronic liver disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>reham elmahdy</last_name>
    <phone>+201002714637</phone>
    <email>reham.elmahdy@aun.edu.eg</email>
  </overall_contact>
  <reference>
    <citation>Ehara S, Ueda M, Naruko T, Haze K, Itoh A, Otsuka M, Komatsu R, Matsuo T, Itabe H, Takano T, Tsukamoto Y, Yoshiyama M, Takeuchi K, Yoshikawa J, Becker AE. Elevated levels of oxidized low density lipoprotein show a positive relationship with the severity of acute coronary syndromes. Circulation. 2001 Apr 17;103(15):1955-60. doi: 10.1161/01.cir.103.15.1955.</citation>
    <PMID>11306523</PMID>
  </reference>
  <reference>
    <citation>Trabetti E, Biscuola M, Cavallari U, Malerba G, Girelli D, Olivieri O, Martinelli N, Corrocher R, Pignatti PF. On the association of the oxidised LDL receptor 1 (OLR1) gene in patients with acute myocardial infarction or coronary artery disease. Eur J Hum Genet. 2006 Jan;14(1):127-30. doi: 10.1038/sj.ejhg.5201513.</citation>
    <PMID>16251892</PMID>
  </reference>
  <reference>
    <citation>Zhao X, Zhang HW, Xu RX, Guo YL, Zhu CG, Wu NQ, Gao Y, Li JJ. Oxidized-LDL is a useful marker for predicting the very early coronary artery disease and cardiovascular outcomes. Per Med. 2018 Nov;15(6):521-529. doi: 10.2217/pme-2018-0046. Epub 2018 Oct 26.</citation>
    <PMID>30362886</PMID>
  </reference>
  <reference>
    <citation>Raut MS, Maheshwari A. Oxygen supplementation in acute myocardial infarction: To be or not to be? Ann Card Anaesth. 2016 Apr-Jun;19(2):342-4. doi: 10.4103/0971-9784.179594. No abstract available.</citation>
    <PMID>27052081</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>Oxidized-LDL</keyword>
  <keyword>OLR1 gene</keyword>
  <keyword>Single nucleotide polymorphism</keyword>
  <keyword>Oxygen therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03830138
org study id: Acute coronary syndrome
nct id: NCT03830138
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a
      younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor
      for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk
      factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of
      the present study was to examine the role of ox-LDL as a risk factor for the presence and
      clinical outcomes in patients with MI.
Cardiovascular disease, which is multifactorial and caused by complex interactions of genetic
      and environmental factors, represents the main cause of death all over the world. Traditional
      risk factors for coronary atherosclerosis include age, smoking, male gender, hypertension and
      diabetes. Newly defined risk factors such as hyper-homocysteine, elevated plasma levels of
      OxLDL and oxidative stress are also emerging.

      Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is the major receptor of
      oxidized low-density lipoproteins which regulates the growth of a variety of cells and is
      important in inflammation, atherosclerosis, oxidative stress, and tissue remodeling. LOX-1 is
      expressed in various cells, including endothelial cells, macrophages, and chondrocytes, and
      its expression is enhanced by proinflammatory cytokines. The LOX1 gene, also known as OLR1,
      is located on the chromosome 12p13.1-p12.3. The LOX1 protein is synthesized as a 40-kDa
      precursor protein and is composed of four domains: an extracellular lectin-like domain at the
      C-terminal, a connecting neck domain, a transmembrane domain, and an N-terminal cytoplasmic
      domain. Three single nucleotide polymorphism (SNPs), namely, intron 4 (G→A), intron 5(T→G),
      and 3' UTR (T→C) in the LOX1 gene, have been previously reported. These polymorphisms have
      also been associated with CAD.

      Oxygen is a lifesaving drug. Giving oxygen to a patient with an impending clinical emergency
      has become knee-jerk reflex reaction of the clinician. Patient with AMI has compromised
      myocardial perfusion and event arises due to myocardial hypoxia. It appears quite logical and
      biologically plausible to give oxygen in such situations to improve the oxygenation of the
      ischemic myocardial tissue and decrease ischemic pain. On the other side, oxygen may be
      harmful with a mechanism such as the paradoxical effect of oxygen in decreasing coronary
      artery blood flow and increasing coronary vascular resistance due to increased oxygen free
      radicals. The investigators aimed to examine the association of the OLR1 gene with AMI or CAD
      in a novel, well-phenotyped, and homogenous, population and its correlation with oxygen
      therapy in these patients.
observational model: Case-Control
time perspective: Cross-Sectional
measure: The mean difference of oxidized-LDL gene polymorphism between patients and controls
time frame: Baseline
description: The mean difference of oxidized-LDL gene polymorphism will be assessed by RFLP. The change of single nucleotide polymorphism of oxidized-LDL from healthy controls at baseline
arm group label: Acute coronary syndrome patients:
description: One hundred patients with acute coronary syndrome.
arm group label: Controls:
description: Fifty healthy control
intervention type: Genetic
intervention name: Oxidized-LDL gene polymorphism
description: Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA
arm group label: Acute coronary syndrome patients:
arm group label: Controls:
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: reham elmahdy
phone: +201002714637
email: reham.elmahdy@aun.edu.eg
citation: Ehara S, Ueda M, Naruko T, Haze K, Itoh A, Otsuka M, Komatsu R, Matsuo T, Itabe H, Takano T, Tsukamoto Y, Yoshiyama M, Takeuchi K, Yoshikawa J, Becker AE. Elevated levels of oxidized low density lipoprotein show a positive relationship with the severity of acute coronary syndromes. Circulation. 2001 Apr 17;103(15):1955-60. doi: 10.1161/01.cir.103.15.1955.
PMID: 11306523
citation: Trabetti E, Biscuola M, Cavallari U, Malerba G, Girelli D, Olivieri O, Martinelli N, Corrocher R, Pignatti PF. On the association of the oxidised LDL receptor 1 (OLR1) gene in patients with acute myocardial infarction or coronary artery disease. Eur J Hum Genet. 2006 Jan;14(1):127-30. doi: 10.1038/sj.ejhg.5201513.
PMID: 16251892
citation: Zhao X, Zhang HW, Xu RX, Guo YL, Zhu CG, Wu NQ, Gao Y, Li JJ. Oxidized-LDL is a useful marker for predicting the very early coronary artery disease and cardiovascular outcomes. Per Med. 2018 Nov;15(6):521-529. doi: 10.2217/pme-2018-0046. Epub 2018 Oct 26.
PMID: 30362886
citation: Raut MS, Maheshwari A. Oxygen supplementation in acute myocardial infarction: To be or not to be? Ann Card Anaesth. 2016 Apr-Jun;19(2):342-4. doi: 10.4103/0971-9784.179594. No abstract available.
PMID: 27052081
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Reham I El-mahdy
investigator title: Principal Investigator
mesh term: Acute Coronary Syndrome
mesh term: Syndrome