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IRCT20220516054874N12 IRCT 2023-09-23 Mashhad University of Medical Sciences Evaluation of the effects of hawthorn extract on left ventricular ejection fraction in patients with Anterior ST segment elevation acute myocardial infarction treated with primary PCI Evaluation of the effects of hawthorn extract (Crataegus monogyna) on left ventricular ejection fraction in patients with Anterior ST segment elevation acute myocardial infarction (Anterior STEMI) treated with primary PCI 2023-10-07 anticipated 60 Complete https://irct.ir/trial/72724 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 15 blocks according to the sample size of 60. Then random numbers between 1 and 15 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Blinding will performed using sealed envelopes. Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 2-3 Acute anterior ST elevation Myocardial infarction treated with primary PCI. Intervention 1: Intervention group: Patients with Anterior ST-segment elevation acute myocardial infarction treated with primary PCI receiving Crataegus monogyna extract tablet (400 mg, prepared by Dineh company) twice a day for one 40 days along with standard treatment. Intervention 2: Control group: Patients with Anterior ST-segment elevation acute myocardial infarction treated with primary PCI receiving placebo tablet with the same shape and size twice a day for one 40 days along with standard treatment. 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with Anterior ST-segment elevation acute myocardial infarction according to the American College of Heart criteria Consent to admission to the study Age more than 18 years old 18 years no limit Both Kidney failure under hemodialysis Severe liver failure with liver enzymes three times more than normal History of using medicinal products containing Crataegus monogyna extract History of heart disease and important valvular diseases in recent echocardiography I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention group: Patients with Anterior ST-segment elevation acute myocardial infarction treated with primary PCI receiving Crataegus monogyna extract tablet (400 mg, prepared by Dineh company) twice a day for one 40 days along with standard treatment. Control group: Patients with Anterior ST-segment elevation acute myocardial infarction treated with primary PCI receiving placebo tablet with the same shape and size twice a day for one 40 days along with standard treatment. Left ventricle ejection fraction. Timepoint: At the beginning of the study and after 40 days of treatment. Method of measurement: Echocardioghraphy. Changes in pulmonary artery pressure. Timepoint: At the beginning of the study and after 40 days of treatment. Method of measurement: Echocardioghraphy. Left ventricular end‐diastolic volume. Timepoint: At the beginning of the study and after 40 days of treatment. Method of measurement: Echocardioghraphy. Mashhad University of Medical Sciences Approved 2023-05-01 Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad Imam Reza Hospital educational complex building, Imam Reza Hospital, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)