Early Beta-Blocker Administration in Patients With ST Segment Elevation Myocardial Infraction and SCAI B Status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of patients progressed from SCAI B to SCAI C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
Patients treated with Metoprolol 25mg
干预措施: Metoprolol (MET) (Drug)
Placebo
Patients treated with matching placebo
干预措施: Plcacebo (Drug)
结局指标
主要结局
Number of patients progressed from SCAI B to SCAI C
时间窗: 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
次要结局
- Rate of in-hospital mortality(during index admission - expected up to 7 days)
- Minor adverse events(3 days from enrollment)
- Hospitalizion duration(During index admission - expected up to 7 days)
- Ejection fraction at 30 days(30 days)
- Need for Mechanical ventilation(During index admission - expected up to 7 days)