ST-elevation myocardial infarction (STEMI) is a type of acute heart attack characterized by the elevation of the ST segment in two adjacent leads on an electrocardiogram (ECG).. ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention 1: Intervention group: A total of 79 patients with AMI, matched for age and sex with the control group, will be randomly assigned to the treatment group receiving Sacubitril/Valsartan. Cl
and at 3 months and 6 months. Three different doses of the drug are available to the researchers: Sacubitril/Valsartan 26/24 mg, 51/49 mg, and 103/97 mg, which are administered twice daily. Treatment
and at 3 months and 6 months. Three different doses of the drug are available to the researchers. Enalapril 2.5 mg, 5 mg, and 10 mg, administered twice daily. Treatment is initiated at the lower dose,
Sponsors
Rasht University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: First-time ST-segment elevation myocardial infarction (STEMI) according to the latest ESC guidelines Timely primary percutaneous coronary intervention within 12 hours of symptom onset Obtaining written informed consent Age between 18 and 75 years
Exclusion criteria
Exclusion criteria: History of heart failure Clinical instability at the time of randomization (requiring intravenous diuretics, vasopressors, or inotropic agents within the 24 hours prior to randomization) eGFR 5.2 mmol/L History of angioedema Intolerance to ACE inhibitors (ACEI) or ARBs History of malignancy with life expectancy less than 1 year Pregnant or breastfeeding women History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent placement or CABG, or planned open-heart surgery within the past 3 months Patients with Takotsubo cardiomyopathy or myocardial infarction secondary to other medical conditions such as anemia, hypotension, arrhythmia, or coronary artery spasm History of liver failure or history of cirrhosis with evidence of portal hypertension Known or suspected bilateral renal artery stenosis Psychiatric, behavioral, or cognitive disorders severe enough to impair the patient’s ability to understand, comply with protocol instructions, or complete follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality. Timepoint: Each patient will undergo follow-up at 4 weeks, 3 months, and 6 months after PPCI. Method of measurement: Recording the number of deaths due to cardiovascular causes.;Rehospitalization. Timepoint: Each patient will undergo follow-up at 4 weeks, 3 months, and 6 months after PPCI. Method of measurement: Recording the number of rehospitalization after PPCI.;Left ventricular ejection fraction. Timepoint: Each patient will undergo follow-up at 4 weeks, 3 months, and 6 months after PPCI. Method of measurement: Recording of LVEF. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Patients will be evaluated at 2 weeks, 4 weeks, 3 months, and 6 months for the occurrence of drug-related adverse effects, including laboratory abnormalities such as hyperkalemia and elevated creatinine. Method of measurement: Blood test.;Need for repeat revascularization. Timepoint: Recording cases requiring repeat revascularization within 6 months of the initial revascularization. Method of measurement: Recording the number of cases requiring repeat revascularization within 6 months of the initial revascularization. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoroush Ahmadi Machiani
Rasht University of Medical Sciences
Outcome results
None listed