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IRCT20250922067324N1 IRCT 2025-09-26 Khoram-Abad University of Medical Sciences effects of nitroglycerin, warm saline , and adenosine on coronary blood flow improvement. Comparative analysis of the effects of intracoronary injection nitroglycerin, warm saline , and adenosine prior to stenting; on post-stenting coronary blood flow improvement in patients presenting with acute myocardial infarction 2025-10-23 anticipated 120 Complete https://irct.ir/trial/86345 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated to four groups using block randomization with a block size of 8 (randomization unit: each patient). The random sequence will be generated by an independent statistician using statistical software; all possible combinations of the four groups within blocks of 8 will be created and randomly ordered until the final sequence for 120 patients is obtained. The sequence will be kept in sequentially numbered, opaque, sealed envelopes, which will be opened at the time of patient enrollment, Blinding description: Patients will not be informed about the specific treatment group to which they are assigned; however, informed consent will be obtained prior to enrollment, and they will be aware that allocation is random to one of four treatment groups. The random sequence will be generated by an independent statistician and kept in sequentially numbered, opaque, sealed envelopes. At patient enrollment, the corresponding envelope will be opened, and the assigned intervention will be prepared and administered. The clinical team will be instructed not to disclose allocation to the patient, and all procedures will be documented. Thus, the study will be conducted in a single-blind manner. 4 Acute Myocardial Infarction. Intervention 1: Control group: After wire passage, with or without balloon, and before stent implantation, no drug will be administered. Intervention 2: Intervention group: First Intervention group: After wire passage, with or without balloon, and before stent implantation, 20 ml of normal saline warmed to 37°C will be injected via the guiding catheter. Intervention 3: Intervention group: Second Intervention group: After wire passage, with or without balloon, and before stent implantation, 100 µg of nitroglycerin will be administered intracoronary via the guiding catheter. Intervention 4: Intervention group: Third Intervention group: After wire passage, with or without balloon, and before stent implantation, 50 µg of adenosine will be administered intracoronary via the guiding catheter. Yes - There is a plan to make this available What will be shared: Individual participant data, after de-identification, limited to the main outcome variables (such as TIMI flow grade), will be available. Data will be shared upon reasonable request from qualified researchers and after approval by the Ethics Committee. No confidential or identifying information of patients will be released. When: Access to de-identified data will be available starting 6 months after publication of the study results and will continue for 3 years. To whom: De-identified data will be available only to researchers affiliated with academic institutions or recognized scientific centers. Access will be granted upon formal request and approval by the Ethics Committee. Conditions: De-identified data will be used solely for research and academic purposes; commercial or unrelated use is not permitted. Analyses must be limited to scientific topics related to cardiovascular diseases. Applicants are required to submit a research proposal, and access will be granted only after approval by the Ethics Committee. Where to obtain: For access to the study data, applicants may contact the principal investigator: Name: Dr. Amir Shakeri Position: Principal Investigator Email: Shakarami.amir@yahoo.com Phone: 0098 66 633120155 Address: Lorestan University of Medical Sciences, Km 4, Khorramabad-Borujerd Road, Khorramabad, Lorestan, Iran How to obtain: Applicants requesting access to the data should follow these steps: 1. Submit a formal request to the principal investigator via email or mail. 2. Provide a short research proposal including objectives, methods, and planned analyses. 3. The proposal will be reviewed and approved by the Ethics Committee. 4. Upon approval, de-identified data will be provided in a secure format along with usage instructions. The total process usually takes 4 to 6 weeks from the date of request to data delivery. Comments:
public Amir shakarami
Mahya building, golshan2 alley, pasdaran street, khorramabad city, lorestan province
Khorramabad Iran (Islamic Republic of) 6814989676 +98 66 3323 9434 Shakarami.amir@yahoo.com Khoram-Abad University of Medical Sciences scientific Amir shakarami
Mahya building, golshan2 alley, pasdaran street, khorramabad city, lorestan province
Khorramabad Iran (Islamic Republic of) 6814989676 +98 66 3323 9434 Shakarami.amir@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Age between 18-80 years old chest pain candidate for primary Percutaneous coronary intervention (primary PCI) Angioplasty within 12 hours of the onset of the first chest pain symptoms presence of ST-segment elevation in two contiguous leads at least 1 millimeter presence of acute Left Bundle Branch Block (LBBB) SBP≥90 mm-hg definite diagnosis of No-Reflow -Slow flow with Thrombolysis in Myocardial Infarction (TIMI) grade ≤2 on the first diagnostic injection patients with an Ejection Fraction(EF) above 20%. 18 years 80 years Both presence of severe valve disease or congenital heart disease known allergic reaction to nitroglycerine or adenosine contraindication of aspirin or clopidogrel cardiomyopathy pericarditis pregnancy 121 myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset Treatment - Other Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: After wire passage, with or without balloon, and before stent implantation, no drug will be administered. Intervention group: First Intervention group: After wire passage, with or without balloon, and before stent implantation, 20 ml of normal saline warmed to 37°C will be injected via the guiding catheter. Intervention group: Second Intervention group: After wire passage, with or without balloon, and before stent implantation, 100 µg of nitroglycerin will be administered intracoronary via the guiding catheter. Intervention group: Third Intervention group: After wire passage, with or without balloon, and before stent implantation, 50 µg of adenosine will be administered intracoronary via the guiding catheter. Coronary blood flow after stent implantation, assessed by Thrombolysis in Myocardial Infarction (TIMI) score. Timepoint: Before and immediately after stent implantation. Method of measurement: TIMI Flow grade. Systolic blood pressure. Timepoint: Before and after stent implantation. Method of measurement: Manual sphygmomanometer. Left Ventricular Ejection Fraction. Timepoint: Before and after stent implantation. Method of measurement: Echocardiography. Khoram-Abad University of Medical Sciences Approved 2025-06-07 Ethics committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Kilometer 4, Khorramabad–Borujerd Road, Khorramabad, Lorestan Province Khorramabad Lorestan Iran (Islamic Republic of)