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

The aim of this study is to determine the impact of administering adenosine during coronary angioplasty on the clinical outcomes of primary angioplasty in patients with acute myocardial infarction with ST segment elevation who are referred to Heshmat Heart Hospital.

Randomized, parallel-group, triple-blind, phase 3 clinical trial on 120 patients. In this study, consecutive patients with acute STEMI, willing to participate in the study, who meet the entry criteria and do not have the exit criteria, and of both sexes, who are 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.

Heshmat Rasht Hospital

Patients with acute STEMI undergoing primary PCI. Inclusion criteria: diagnosis of STEMI in the emergency department, meeting criteria for primary PCI, TIMI flow 0-0-1 grade = coronary angiography, and informed consent. Exclusion criteria: cardiac shock, complete AV block, severe renal failure (serum creatinine > 3 mg/dL), need for emergency coronary artery bypass surgery, and history of coronary revascularization.

Patients are included in the study based on daily visits in groups A (Adenosine injection) and group C (without 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. (25) Measurement periods: during forty days after the intervention How to measure the variable: All patients will be followed up for MACE for 40 days, either through a clinic visit or through a telephone interview.

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.

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.

All data except personal information (name, contact number, file number) can be published.

After publishing the results

Available to service providers such as doctors and nurses.

After obtaining permission from the project manager, the information will be usable.

Project manager

By email to the project manager

-