Early Beta Blocker Administration in STEMI Patients With SCAI B Status

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel-Aviv Sourasky Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Inability to provide informed consent.

Evidence of pulmonary edema.

Bradycardia (heart rate <60 beats per minute).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metoprolol (MET)

    Drug

    Administration of metoprolol 25 mg twice daily

  • Plcacebo

    Drug

    Administration of matching placebo

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients progressed from SCAI B to SCAI C

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

Time frame
3 days from enrollment

Secondary outcomes

1

Rate of in-hospital mortality

The mortality rate of patients during index admission

Time frame
during index admission - expected up to 7 days
2

Need for Mechanical ventilation

The rate of patients that will require mechanical ventilation

Time frame
During index admission - expected up to 7 days
3

Minor adverse events

minor events including tachyarrhythmia, bradyarrhythmia, AV blocks

Time frame
3 days from enrollment
4

Hospitalizion duration

Time of index hospitalization

Time frame
During index admission - expected up to 7 days

Other outcomes

Sponsors and contacts

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