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IRCT20151028024756N3 IRCT 2018-07-28 Bandare-abbas University of Medical Sciences Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, SIRT1, p53, eNOSox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients 2018-05-22 anticipated 100 Complete https://irct.ir/trial/29097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on random numbers, Blinding description: Only one of the researchers who are not involved in data analyzing and not related to the patient treatment is responsible for dividing patients between the two groups. 3 Patients with high blood pressure and Hyperlipidemic with a small plaque in one of the coronary arteries. Intervention 1: Patients with CAD (moderate coronary artery disease) under 60% who will chose for intervention group after angiography. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected from the patients. The weight, blood pressure,waist and hip circumference of the patient are checked and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression. . Along with their routine treatment they will receive 300 mg/ day of oral magnesium sulfate from Neyak Company, which is taken with food for one year and they will follow up every three months. Blood samples are taken at each visit from the patient to measure the variables, the patient's weight, blood pressure, waist and hip circumference are also checked. Intervention 2: Control group: Patients with CAD under 60% who also will chose after angiography for control group. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression . This group will receive placebo which is made by Neyak Corporation with the same shape as intervention group. These patients are also followed up once every three months for a period of one year. In each visit, blood sample will be taken to measure study's variables and blood pressure, weight, waist and hip circumference of the patient will be checked. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This decision will be made based on the patient's satisfaction in the future
public Nepton Soltani
Hezar Gerib
Isfahan Iran (Islamic Republic of) 987654321 +98 31 3792 8019 solnep2002@yahoo.com Esfahan University of Medical Sciences scientific Nepton Soltani
Hezar Jerib
Isfahan Iran (Islamic Republic of) 987654321 +98 31 3792 8019 solnep2002@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 1. Moderate coronary artery disease<60 -2. Age of women and men should be more than 55 years and 45 years respectively. 3.Also people that are diabetic, hypertension, hyperlipidemia , smoker and insulin resistance will be entered in the study. 45 years no limit Both 1.Age of women be less than 55 years,2. pregnant women3. patients who are using magnesium and calcium containing supplements 4. patients who have experienced renal insufficiency (serum creatinine levels more than 1.3 mg/dl in women and more than 1.5 mg/dl in men). 5- elevated hepatic enzymes (more than 3 folds over normal values),recent infections (less than one month prior to study) and chronic inflammatory diseases, cerebrovascular accident(CVA), also cancer and drug sensetivity I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris Treatment - Drugs Treatment - Drugs Patients with CAD (moderate coronary artery disease) under 60% who will chose for intervention group after angiography. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected from the patients. The weight, blood pressure,waist and hip circumference of the patient are checked and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression. . Along with their routine treatment they will receive 300 mg/ day of oral magnesium sulfate from Neyak Company, which is taken with food for one year and they will follow up every three months. Blood samples are taken at each visit from the patient to measure the variables, the patient's weight, blood pressure, waist and hip circumference are also checked. Control group: Patients with CAD under 60% who also will chose after angiography for control group. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression . This group will receive placebo which is made by Neyak Corporation with the same shape as intervention group. These patients are also followed up once every three months for a period of one year. In each visit, blood sample will be taken to measure study's variables and blood pressure, weight, waist and hip circumference of the patient will be checked. Hypertension- Hyperlipidemic- Atherosclerosis. Timepoint: every three months. Method of measurement: Barometer device and appropriate kits. Size of Atherosclerosis plaque. Timepoint: After one year. Method of measurement: With Angiography if patient satisfies. Bandare-abbas University of Medical Sciences Approved 2018-11-23 Research Ethics Committee of Hormozgan University of Medical Sciences Emam Hossein Blv. Faculty of MedicineŁˆ Hormozgan University of Medical Science bandar abbas Hormozgan Iran (Islamic Republic of)