Cardiogenic Shock Post Myocardial Infarction, ST Segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
acute MI, stemi, beta blockers
Brief summary
This study is looking at how a medication called beta-blockers (metoprolol) affects patients with a heart attack (STEMI) who are in the cardiac intensive care unit. When patients are admitted to the unit, they will be randomly placed in one of two groups. One group will get the metoprolol medication, and the other will receive a placebo (a harmless pill that looks like the real medication). All other treatments will be the same for both groups. During the study, which is 72 hours long, patients will be monitored for blood pressure, heart rate, and lactate levels alterations. The main goal is to see if the medication helps improve patients condition or prevent it from getting worse. patients safety is a top priority, and if needed, the doctors can stop the study at any time if there are concerns.
Detailed description
A prospective, randomized, double-blind cohort study will be conducted on patients with STEMI who are hospitalized in the cardiac intensive care unit and classified as SCAI B at the time of admission by the attending physician. Patients will be identified upon admission to the unit and randomized into two arms - a control group and an intervention group. Randomization will be performed using sealed envelopes. A block randomization model will be used based on LVEF estimation of \>40% or ≤40%. In the intervention group, patients will receive standard beta-blocker treatment, specifically low-dose metoprolol at 25 mg twice daily. In the control group, patients will receive a placebo. All other standard treatments will be identical between the two study groups, in accordance with the unit's treatment protocol and the clinical status of the patients. As an integral part of this treatment, patients will be continuously monitored for parameters including blood pressure, heart rhythm, and blood lactate levels. The treatment duration under this protocol will be 72 hours or until the occurrence of the primary outcome, whichever comes first. The primary outcome is defined as progression of the patient's condition to SCAI C, according to accepted criteria, including an increase in lactate levels, a decrease in urine output, or a change in mental status. Per guidelines, every 24 hours, investigators will re-evaluate each patient. If they meet current criteria for beta-blocker administration (SCAI A status and no contraindications), the study drug will be terminated and active metoprolol will be prescribed. To ensure patient safety, the treating staff will have the option to request unblinding of the patient's allocation at any time. Additionally, after the enrollment of 100 patients (or after one year, whichever comes first), an interim analysis of the data will be conducted to ensure the study remains within established safety parameters. An echocardiogram and follow-up visit will be performed at 30 days.
Interventions
DRUGMetoprolol (MET)
Administration of metoprolol 25 mg twice daily
DRUGPlcacebo
Administration of matching placebo
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
A prospective, randomized, double-blind cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ST-segment elevation myocardial infarction (STEMI) confirmed by ECG, clinical signs, and coronary catheterization. * Post-catheterization patients classified as SCAI B upon admission to the unit, defined by the presence of tachycardia and/or hypotension without signs of hypoperfusion (i.e., normal lactate levels, normal capillary refill, preserved mental status, and adequate urine output \>0.5 mL/kg/hour). * Age 18 years or older. * Mentally competent to provide informed consent, understand the study procedures, and comply with medical recommendations.
Exclusion criteria
* Pregnancy. * Inability to provide informed consent. * Evidence of pulmonary edema. * Bradycardia (heart rate \<60 beats per minute). * PR interval \>240 milliseconds. * Second- or third-degree atrioventricular (AV) block. * Active asthma. * Known hypersensitivity to metoprolol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients progressed from SCAI B to SCAI C | 3 days from enrollment | number of patients who progressed from SCAI B to SCAI C as measured by - Serum lactate levels \> mmol/L urinary output \> 0.5 ml/kg/hour slow capillary filling Change in mental status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of in-hospital mortality | during index admission - expected up to 7 days | The mortality rate of patients during index admission |
| Need for Mechanical ventilation | During index admission - expected up to 7 days | The rate of patients that will require mechanical ventilation |
| Minor adverse events | 3 days from enrollment | minor events including tachyarrhythmia, bradyarrhythmia, AV blocks |
| Hospitalizion duration | During index admission - expected up to 7 days | Time of index hospitalization |
| Ejection fraction at 30 days | 30 days | Ejection fraction as measured by echocardiography at 30 days |
Countries
Israel
Contacts
Primary ContactShir Frydman, MD
Backup ContactYishay Szekely, MD
Outcome results
None listed