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IRCT20211129053210N1 IRCT 2021-12-19 Hamedan University of Medical Sciences Comparison of drug therapy with percutaneous coronary intervention Comparison of drug therapy with percutaneous coronary intervention in the treatment of chronic stable angina 2022-01-20 anticipated 100 Complete https://irct.ir/trial/60282 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: stratified randomization by gender: An equal number of men and women participate in each group. The samples will be determined by Permuted block randomization using the table of random numbers of Allocation Random software. In this 2-group trial, 2 blocks of 50, including 25 participants in the intervention group and 25 participants in the medical group are selected. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. N/A Chronic Ischemic Heart Disease. Intervention 1: Control group: Cardiac ischemia drugs. Intervention 2: Intervention group: Cardiac ischemia drugs with percutaneous coronary intervention. Yes - There is a plan to make this available What will be shared: Age, gender, ejection fraction, emergency department visit, number of hospitalizations, quality of life and function class . Can be shared after unidentified people. When: Access period starts from 2022 To whom: Researchers working in academic and scientific institutions Conditions: Provide appropriate treatment to patients with chronic stable angina Where to obtain: Dr.Mohammad Mahdi Monajjem Farshchian Cardiovascular Hospital, Hamadan, Angiography Unit E-mail: m.monajjem97@gmail.com How to obtain: Full introduction with email and contact number. Comments:
public Mahsa Movahedi
Unit 6, No. 405, Javadieh St.
Hamadan Iran (Islamic Republic of) 8176763746 +98 81 3838 8078 mahsa.movahedi@ymail.com Hamedan University of Medical Sciences scientific Mohammad Mahdi Monajjem
Unit 6, No. 405, Javadieh St.
Hamadan Iran (Islamic Republic of) 8176763746 +98 81 3838 8078 mahsa.movahedi@ymail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) More than 70% stenosis in at least one coronary artery EF more than 30% no limit no limit Both Resistant angina class IV Treatment-resistant heart failure Cardiogenic shock Anatomy inappropriate for PCI Chronic renal failure Proximal LAD obstruction triple vessel disease Diabetes, smoker I25.9 Chronic ischemic heart disease, unspecified Treatment - Drugs Treatment - Devices Control group: Cardiac ischemia drugs Intervention group: Cardiac ischemia drugs with percutaneous coronary intervention Quality of life: In terms of the patient's clinical symptoms and based on the chronic angina checklist. Timepoint: Measurement of quality of life at the beginning of the study and 6 months after the intervention. Method of measurement: Chronic angina checklist. Go to the emergency room based on the patient's statements. Timepoint: Evaluation of emergency department visit 6 months after the intervention. Method of measurement: Based on the patient's statements. Number of hospitalizations based on hospitalization documents. Timepoint: Evaluation of the number of hospitalizations 6 months after the intervention. Method of measurement: Based on hospitalization documents. Function Class: Angina classification based on the New York Heart Association. Timepoint: Evaluation of class function at the beginning of the study and 6 months after the intervention. Method of measurement: Based on the patient's statements and New York Heart Association. Ejection fraction based on echocardiographic findings. Timepoint: Ejection fraction at the beginning of the study and 6 months after the intervention. Method of measurement: Based on the patient's echocardiographic evidence. Hamedan University of Medical Sciences Approved 2021-11-27 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences ,Shahid Fahmideh St. Hamadan Hamadan Iran (Islamic Republic of)