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Oxidized LDL With Oxygen Therapy in Acute Coronary Syndrome.

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ClinicalTrials.gov Identifier: NCT03830138
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Reham I El-mahdy, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Genetic: Oxidized-LDL gene polymorphism

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Oxidized LDL, Oxidized LDL Receptor 1 (OLR1) Gene Polymorphism With Oxygen Therapy in Acute Myocardial Infarction.
Estimated Study Start Date : February 20, 2019
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute coronary syndrome patients:
One hundred patients with acute coronary syndrome.
Genetic: Oxidized-LDL gene polymorphism
Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA

Controls:
Fifty healthy control
Genetic: Oxidized-LDL gene polymorphism
Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA




Primary Outcome Measures :
  1. The mean difference of oxidized-LDL gene polymorphism between patients and controls [ Time Frame: Baseline ]
    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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Acute coronary syndrome patients
Criteria

Inclusion Criteria:

  • Patients were included irrespective of concomitant risk factors for atherosclerosis such as smoking, arterial hypertension and diabetes mellitus.
  • Participants were both sexes.

Exclusion Criteria:

  • Congenital heart disease.
  • Dilated, hypertrophic or restrictive cardiomyopathy.
  • acute and chronic liver disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830138


Contacts
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Contact: reham elmahdy +201002714637 reham.elmahdy@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Reham I El-mahdy, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03830138     History of Changes
Other Study ID Numbers: Acute coronary syndrome
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reham I El-mahdy, Assiut University:
Oxidized-LDL
OLR1 gene
Single nucleotide polymorphism
Oxygen therapy
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases