]>
IRCT20210625051701N1 IRCT 2021-07-24 Esfahan University of Medical Sciences Prevalence of unstable ventricular tachycardia using Holter monitoring in patients with myocardial infarction with cardiac output less than 35% Prevalence of non-sustained ventricular tachycardia in patients with STEMI with left ventricular ejection fraction (LVEF)<35 using holter monitoring at post-discharge intervals at Chamran hospital and its effect on major adverse cardiac events 2021-08-11 anticipated 110 Complete https://irct.ir/trial/57590 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The randomization method is such that the samples are randomly divided into two groups with the help of random allocation software 2.0 designed by Dr. Mahmoud Saghaei. Patients are assigned to one of the two groups in order of enrollment by number. This is done by a nurse outside the research team and the groups are marked with the letters A and B. N/A ST elevation myocardial infarction (STEMI). Intervention 1: Intervention Intervention group: Patients with myocardial infarction with cardiac output less than 35% undergoing PCI . In the intervention group, forty days after admission, patients underwent cardiac rhythm monitoring four times in ten days intervals with a 24-hours Holter monitoring device, and the results were recorded. Each time the patient's rhythm changes will be interpreted by an electrophysiologist and the patient's arrhythmias will be recorded in a questionnaire. If there is intermittent ventricular tachycardia (less than 30 seconds) in the Holter monitoring, patients will be electrophysiologically studied by an electrophysiologist and in the case of ventricular tachycardia, ICD will be implanted. Finally, after three months, patients are contacted and asked about major cardiovascular complications (stroke, re-stroke, cardiovascular death) and information will be documented. Intervention 2: Control group: In the control group, Holter monitoring and electrophysiological study will not be performed. Finally, after three months, patients are contacted and asked about major cardiovascular complications (stroke, re-stroke, cardiovascular death) and information will be documented and will be compared to the intervention group by statistical analysis. Yes - There is a plan to make this available What will be shared: The study results will be published as an article. The study protocol and statistical analysis used in the article will be considered. When: It will be published a year after the study is completed and will be available in the sources. To whom: Information will be made available after permission of the sponsor for academic researchers, physicians, and academic institutions . Conditions: Other researchers can use the results of the study in their review and meta-analysis. Where to obtain: Dr. Afshin Amirpour Angiography subspecialty fellowship Isfahan: Bozorgmehr Square, third Mushtaq Street, after the ُShahrestan bridge. Shahid Chamran Clinic Afshinamirpour.ras@gmail.com 0913 107 2678 How to obtain: upon request, the corresponding author will respond after consulting with the sponsor of the study. Comments:
public Afshin Amirpour
Bozorgmehr Square, third Mushtaq Street, after the Shahrestan bridge. Shahid Chamran Clinic
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 107 2678 Afshinamirpour.ras@gmail.com Esfahan University of Medical Sciences scientific Afshin Amirpour
Bozorgmehr Square, third Mushtaq Street, after the Shahrestan bridge. Shahid Chamran Clinic
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 107 2678 Afshinamirpour.ras@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Over 18 years old Consent to enter the study Myocardial infarction (ST-segment elevation of one millimeter or more in at least two adjacent leads) with heart failure (LVEF <35%) 18 years no limit Both Dissatisfaction with the study Previous history of myocardial infarction Having life-threatening diseases before having a myocardial infarction Patients with left bundle branch block on electrocardiogram Patients with dangerous cardiac conditions who are bedridden Previous history of arrhythmia Previous history of chronic heart failure Monomorphic arrhythmia in the first 24 hours Patients who have undergone CABG Previous history of chronic renal failure I21 ST elevation myocardial infarction (STEMI) Diagnosis Diagnosis Intervention Intervention group: Patients with myocardial infarction with cardiac output less than 35% undergoing PCI . In the intervention group, forty days after admission, patients underwent cardiac rhythm monitoring four times in ten days intervals with a 24-hours Holter monitoring device, and the results were recorded. Each time the patient's rhythm changes will be interpreted by an electrophysiologist and the patient's arrhythmias will be recorded in a questionnaire. If there is intermittent ventricular tachycardia (less than 30 seconds) in the Holter monitoring, patients will be electrophysiologically studied by an electrophysiologist and in the case of ventricular tachycardia, ICD will be implanted. Finally, after three months, patients are contacted and asked about major cardiovascular complications (stroke, re-stroke, cardiovascular death) and information will be documented. Control group: In the control group, Holter monitoring and electrophysiological study will not be performed. Finally, after three months, patients are contacted and asked about major cardiovascular complications (stroke, re-stroke, cardiovascular death) and information will be documented and will be compared to the intervention group by statistical analysis. Prevalence of NSVT. Timepoint: Every ten days for the first 40 days after discharge. Method of measurement: Holter monitoring. Incidence of MACE (major cardiac complications including stroke, myocardial infarction and cardiovascular death) in patients. Timepoint: Every ten days for the first 40 days after discharge. Method of measurement: Holter monitoring. Esfahan University of Medical Sciences Approved 2021-01-11 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, School of Medicine Isfahan Isfehan Iran (Islamic Republic of)