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IRCT20220223054103N1 IRCT 2022-04-28 Yazd University of Medical Sciences Effect of Sildenafil on Coronary Slow Flow Phenomenon Effect of Sildenafil on Ischemic Cardiac Clinical and paraclinical manifestations in patients with Coronary Slow Flow Phenomenon : a randomized controlled clinical trial 2022-06-22 anticipated 20 Complete https://irct.ir/trial/62181 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done based on the quadruple block method.The letters A and B will be used to assign the drug and the placebo. Until the drug is assigned, it will not be clear which A and B belong to the drug or the placebo. Only one person (the main executor) is aware. For concealment, the person who performs the randomization and specifies the following arrangements (AABB ,ABAB, ABBA, BBAA, BABA, BAAB) will be different from the person delivering the drug to the patient.For randomization, random order of 4 is noted and each block is placed in a sealed envelope. After registering all the patients, each patient is given a code. After the blocks are randomized, the randomized sequences are numbered sequentially. The person who allocates the drug assigns the prepared drugs to the patient after opening each envelope, Blinding description: A person who is aware of the assignment of the letters A and B to a drug or placebo is only the first executor and project manager. Other people who do randomization and drug allocation and examination and evaluation of patient outcomes and statistical analysis are different people and do not know which letter is assigned to the drug or placebo.The drugs are available to the dispenser in the same form in completely similar packages, and the patient himself is also unaware that he is receiving the drug or placebo. The drug packages are unnamed and are only in boxes A and B. The dispenser and the doctor are not aware of the contents of boxes A and B. 2-3 Coronary Slow Flow Phenomenon. Intervention 1: Intervention group: The use of Sildenafil starts with a daily dose of 50 mg orally and continues for 12 weeks. Intervention 2: Control group: The placebo is started once daily orally and continues like the intervention group until the end of the study. 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 There is no more information.
public Amin Entezari
Jomhuri Blvd
Yazd Iran (Islamic Republic of) ۸۹۱۷۹۴۵۵۵۶ +98 35 3523 1420 aminentezari.2013@gmail.com Yazd University of Medical Sciences scientific Abas Andishmand
Jomhuri Blvd
Yazd Iran (Islamic Republic of) ۸۹۱۷۹۴۵۵۵۶ +98 35 3523 1420 drandishmand@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with definitive diagnosis of CSFP on coronary angiography. Patients with clinical signs of ischemia including typical angina pectoris (at least 2-3 minutes retrosternal and compressive angina) or dyspnea (equivalent to angina). 30 years 70 years Both Patients with myocardial infarction or PCI or CABG or valve replacement or valve repair Patients with Obstructive CAD (stenoses greater than 40%) Patients with hepatic or renal failure or CVA or COPD or Cancer or acute infectious disease such as Covid 19 Patients older than 75 years or less than 30 years Patients with low systolic blood pressure (<90 mmHg) Patients with severe uncontrolled hypertension (> 180/100) Patients with LVEF <50% I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris Treatment - Drugs Placebo Intervention group: The use of Sildenafil starts with a daily dose of 50 mg orally and continues for 12 weeks. Control group: The placebo is started once daily orally and continues like the intervention group until the end of the study. Chest Pain according to Canadian cardiovascular society classification. Timepoint: Begining of the study, 1 , 2 , 3 months after taking sildenafil. Method of measurement: Canadian cardiovascular society classification questionnaire. Duke treadmill score. Timepoint: Begining of the study, 3 months after taking sildenafil or placebo. Method of measurement: Scoring based on the Duke treadmill score. Functional capacity in exercise treadmill test. Timepoint: Begining of the study, 3 months after taking sildenafil or placebo. Method of measurement: Achived METs. ETT changes. Timepoint: begining of the study and 3 months later. Method of measurement: exercise treadmill test. Blood pressure. Timepoint: begining of the study and 1 and 2 and 3 months later. Method of measurement: Blood pressure monitor. Yazd University of Medical Sciences Approved 2022-04-04 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Shahid Sadoughi Blvd Yazd Yazd Iran (Islamic Republic of)