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

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

A phase 4 randomized, single-blind, controlled, parallel-group clinical trial on 120 patients. Randomization will be performed using statistical software.

This clinical trial will include 120 patients with acute myocardial infarction at Shahid Madani Hospital who meet inclusion/exclusion criteria. Patients will be randomly allocated to four intervention groups. After stent implantation, coronary flow will be assessed by TIMI flow grade (0–3) as the primary outcome. Patients will be blinded to allocation, and informed consent will be obtained before enrollment.

Age between 18-80 years old chest pain candidate for primary Percutaneous coronary intervention (primary PCI) Angioplasty within 12 hours of the onset of chest pain symptoms ST elevation of at least 1 millimeter in two contiguous leads presence of acute Left Bundle Branch Block (LBBB) Systolic Blood Pressure≥90 mm-hg definite diagnosis of No-Reflow -Slow flow with Thrombolysis in Myocardial Infarction (TIMI) grade ≤2 on the first diagnostic injection diagnostic injection patients with an ejection fraction above 20%. ; presence of severe valve disease or congenital heart disease known allergic reaction to nitroglycerine or adenosine contraindication of aspirin or clopidogrel cardiomyopathy pericarditis pregnancy

Group 1 (Control): No drug after wire, before stent. Group 2 (Warm saline): 20 ml saline at 37°C. Group 3 (Nitroglycerin): 100 µg intracoronary. Group 4 (Adenosine): 50 µg intracoronary.

coronary blood flow after stent implantation, measured by TIMI flow grade at the end of PCI.

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

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.

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.

Access to de-identified data will be available starting 6 months after publication of the study results and will continue for 3 years.

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.

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.

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

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.