STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Measurement of Global longitudinal strain (GLS, %)
研究概览
简要总结
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)
详细描述
Left ventricular (LV) remodeling after ST-elevation myocardial infarction (STEMI) is associated with poor outcomes, but the mechanisms underlying adverse LV remodeling are poorly understood. It is also poorly understood how current guideline-recommended treatments affect early LV remodeling. This low interventional clinical trial will compare the effects of early versus late initiation of the three pharmacotherapies on early LV remodeling and cardiometabolic profiles.
Trial objective:
The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI).
Primary endpoint:
Global longitudinal strain (GLS, %) at day 7±24 hours after PCI, adjusted for baseline (day 0) GLS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
- •Informed consent
排除标准
- •Killip class ≥ 3
- •Chronic kidney disease with GFR < 25 ml/min/1.73 m2
- •Pre-existing non-reversible cardiac dysfunction or heart failure
- •Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor
- •Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician
- •Life expectancy less than one year
- •Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
研究组 & 干预措施
Bisoprolol
Bisoprolol within 24 hours of PCI
干预措施: Bisoprolol Oral Tablet (Drug)
Ramipril
Ramipril within 24 hours of PCI
干预措施: Ramipril Oral Product (Drug)
Dapagliflozin
Dapagliflozin within 24 hours versus
干预措施: Dapagliflozin Oral Product (Drug)
结局指标
主要结局
Measurement of Global longitudinal strain (GLS, %)
时间窗: day 7±24 hours
GLS adjusted for baseline.
次要结局
- Measurement of Left ventricular ejection fraction (LVEF)(day 7±24 hours)
- Concentration of cardiac troponin-T(Day 30)
- Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )(day 7±24 hours)
- Concentration of cardiac troponin-I(Day 30)