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IRCT20220809055645N6 IRCT 2023-06-07 Rasht University of Medical Sciences The Effect of Intracoronary Adenosine Injection on Outcomes of Primary Percutaneous Intervention in Patients with ST-segment Elevation Myocardial Infarction The Effect of Intracoronary Adenosine Injection on Outcomes of Primary Percutaneous Intervention in Patients with ST-segment Elevation Myocardial Infarction; A randomized controlled clinical trial 2023-06-20 anticipated 120 Complete https://irct.ir/trial/70509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In this study, consecutive patients with acute STEMI, willing to participate in the study, who meet the inclusion criteria and do not have the exclusion criteria, and of both sexes, who are candidates for PPCI, are randomly assigned to two groups using the random block method of 4. According to the sample size (N = 118, approximately 120), 30 random blocks will be generated through the Random Allocation software, Blinding description: The study will be conducted as a triple-blind trial, and the control group will receive the normal saline volume injection just because of blinding purposes. After selecting the samples, neither the participants nor the physicians will have any knowledge about randomization and allocation process to the groups. The physicians will be given a pre-assigned coded number table and will enter the patients into the study according to their table numbers. The drug packages are completely identical in appearance, and both the patients and the study executor are unaware of their contents. Furthermore, data collection, patient assessment, and form completion will be performed by the study executor and their assistant who are also unaware of the drug package contents. In data analysis stage, analysis will be performed by both a consultant researcher and study executor who are also unaware of drug package contents, and only the patient group (group 1 or 2) for data analysis will be determined. Therefore, this is a triple-blind study where drug package contents are not known from patient entry to study completion, data collection, and information analysis. 3 Acute transmural myocardial infarction of unspecified site. Intervention 1: Intervention group: Adenosine injection. Intervention 2: Control group: No adenosine injection/routine care with 5 cc of normal saline. Yes - There is a plan to make this available What will be shared: All data except personal information (name, contact number, file number) can be published. When: After publishing the results To whom: Available to service providers such as doctors and nurses. Conditions: After obtaining permission from the project manager, the information will be usable. Where to obtain: Project manager How to obtain: By email to the project manager Comments: -
public Fatemeh Baharvand
Kooye Bayani
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 dr.baharcardio@gmail.com Rasht University of Medical Sciences scientific Fatemeh Baharvand
Kooye Bayani
Rasht Iran (Islamic Republic of) 41939-55588 +98 13 3366 4282 dr.baharcardio@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Diagnosis of STEMI in the emergency department Having complete criteria for primary PCI TIMI flow grade= 0-0-1 Coronary angiography Informed consent 18 years no limit Both Cardiogenic shock Complete AV block Severe renal failure (serum creatinine> 3 mg/dL) Need for emergency coronary artery bypass surgery History of recurrent coronary artery disease I21.3 ST elevation (STEMI) myocardial infarction of unspecified site Treatment - Drugs Placebo Intervention group: Adenosine injection Control group: No adenosine injection/routine care with 5 cc of normal saline (Major adverse cardiac events) MACE, which in this study is a combination of cardiac death, non-fatal myocardial infarction, any re-angiogenesis and stroke, and are defined according to The Academic Research Consortium. Timepoint: Within forty days after the intervention. Method of measurement: All patients will be followed up for MACE for 40 days, either through clinic visits or telephone interviews. No-reflow phenomenon refers to the lack of blood flow after coronary artery reopening. Timepoint: before and immediately after primary angioplasty. Method of measurement: based on angiographic criteria such as TIMI flow grade and TIMI frame count. ST-segment resolution (STR) is considered if the ST segment returns more than 70% to the isoelectric line 90 minutes after injection. Timepoint: before and 90 minutes after intervention. Method of measurement: Standard 12-lead ECG will be taken from all patients at hospital admission and 90 minutes after PPCI. The sum of ST segment elevation, 20ms after the J point in all leads will be recorded. After calculating the total increase in ST-segment elevation in leads representing the infarct location on the baseline ECG and at minute 90, STR will be expressed as a percentage by dividing the second number by the first number and subtracting it from 100. Left ventricular ejection fraction (LVEF) refers to how well the left ventricle pumps blood with each contraction. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: By a cardiologist with an echocardiography device using the Biplaine Simpson method, then the percentage of LVEF recovery will be calculated as the difference between the initial LVEF and 40 days later. Rasht University of Medical Sciences Approved 2023-05-31 Research Ethics Committees of Guilan University of Medical Sciences Namjoo Rasht Guilan Iran (Islamic Republic of)