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IRCT20210228050528N1 IRCT 2021-10-22 Zanjan University of Medical Sciences Evaluation of the effect of vitamin D before percutaneous coronary intervention in the prevention of cardiovascular complications Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with unstable angina in reducing Major adverse cardiovascular events 2021-10-23 anticipated 76 Complete https://irct.ir/trial/54716 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, patients are divided into simple randomizations using randomly generated computer-generated numbers by an independent individual, Blinding description: In this study, patients will be unaware of the nature of the prescribed drug, that is, after randomly dividing patients into two groups, the first group in addition to routine pre-intervention drugs, treated with vitamin D (three hundred thousand units orally 12 Hours before the intervention), and the second group will receive only routine pre-intervention medications. 3 Condition 1: Major adverse cardiovascular events. Condition 2: Precutaneous coronary intervention. Condition 3: Unstable angina. Intervention 1: Intervention group: A group that, in addition to routine pre-PCI medications, is treated with 300,000 units of oral vitamin D (six 50,000 units of vitamin D tablets produced by Zahravi Pharmaceutical Company) 12 hours before PCI. Intervention 2: Control group: The group that only receives routine medications before PCI. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the primary or secondary outcome, will be shared. When: Access period starts 6 months after the results are published To whom: Researchers in academic and scientific institutions Conditions: The data and documents of the study will be available for the use of other researchers in academic and scientific institutions in relation to related topics with ethical principles. Where to obtain: My e-mail address : Amirshahbazzadeh@yahoo.com How to obtain: The applicant can access the study data and documents after submitting the requirement on reputable sites and online correspondence with me. Comments:
public Amir Shahbazzadeh
No 232, block C, Honarmandan tower, Shariati Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 5819463168 +98 21 6653 5168 amirshahbazzadeh@yahoo.com Zanjan University of Medical Sciences scientific Amir Shahbazzadeh
No 232, block C, Honarmandan tower, Shariati Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 5819463168 +98 21 6653 5168 amirshahbazzadeh@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with unstable angina who are candidates for PCI Patients with deficient serum levels of vitamin D 18 years no limit Both Previous history of myocardial infarction Previous history of revascularization therapy interventions Patients with a previous history of CABG Patients with failed PCI Simultaneous involvement of valvular disorders Take vitamin D, calcium or omega-3 supplements in the last 3 months Patients with hypercalcemia, nephrolithiasis, sarcoidosis, malabsorption syndromes Chronic underlying diseases such as liver, kidney or rheumatic disorders Pregnancy and lactation Having malignancies History of receiving corticosteroids or immunosuppressants in the last 6 months R94.30 Z95.5 I25.110 Abnormal result of cardiovascular function study, unspecified Presence of coronary angioplasty implant and graft Atherosclerotic heart disease of native coronary artery with unstable angina pectoris Treatment - Drugs Treatment - Drugs Intervention group: A group that, in addition to routine pre-PCI medications, is treated with 300,000 units of oral vitamin D (six 50,000 units of vitamin D tablets produced by Zahravi Pharmaceutical Company) 12 hours before PCI. Control group: The group that only receives routine medications before PCI. Number of myocardial infarction cases. Timepoint: 3 and 6 months later. Method of measurement: ECG and echocardiography. Number of revascularization cases in re hospitalization. Timepoint: 3 and 6 months later. Method of measurement: ECG and echocardiography. Readmission rate. Timepoint: 3 and 6 months later. Method of measurement: ECG and echocardiography. Mortality rate. Timepoint: 3 and 6 months later. Method of measurement: In-person and telephone follow-up. Cardiac function. Timepoint: 3 and 6 months later. Method of measurement: In-person follow-up. Zanjan University of Medical Sciences Approved 2021-09-01 Ethics Committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital, Gavazang Boulevard Zanjan Zanjan Iran (Islamic Republic of)