The Impact of Sympathetic Drive Control With Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Infarct Size (CMR)
研究概览
简要总结
Introduction: The effect of intravenous beta-blockers on the extent of the necrotic area, after primary percutaneous transluminal coronary angioplasty (PTCA), for acute myocardial infarction is not well established.
Purpose: The present study aims to investigate, whether the early intravenous administration of landiolol, a highly cardioselective b-blocker, reduces the extent of the necrotic area after ST-elevation myocardial infarction (STEMI).
Methods: This prospective observational cohort study will enroll patients presenting with STEMI, who undergo primary PCI and receive either intravenous landiolol or standard oral β-blocker therapy, in accordance with current European Society of Cardiology (ESC) guidelines. Eligibility will be determined by predefined inclusion and exclusion criteria. Treatment selection will be based solely on the clinical judgment of the attending cardiologist, without randomization.
Results: Final infarct size will be quantified by cardiac magnetic resonance imaging (CMR) performed at least three months after the STEMI to minimize edema-related overestimation. Myocardial function will be assessed during hospitalization using transthoracic echocardiography, including measurement of global longitudinal strain (GLS). Additional data will include serial high-sensitivity troponin and creatine phosphokinase (CPK) measurements, 24-hour continuous electrocardiographic monitoring for arrhythmia burden, and predefined safety outcomes collected throughout hospitalization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Patients with electrocardiogram showing ST-segment elevation ≥2 mm in 2 or more contiguous leads for more than 30 minutes
- •Estimated time from symptom onset to reperfusion ≤12 hours
- •Patients scheduled to undergo primary angioplasty
- •Patients who have signed a consent form
排除标准
- •Patients receiving chronic medication with beta-adrenergic blockers
- •Patients with a previous myocardial infarction
- •Persistent systolic blood pressure <90 mmHg
- •Persistent heart rate <55 beats per minute
- •Patients with Killip class III (acute pulmonary edema) or IV (cardiogenic shock) on initial examination
- •12-lead electrocardiogram with PR interval >200 milliseconds
- •12-lead electrocardiogram showing second- or third-degree atrioventricular block
- •Bronchospasm requiring bronchodilator treatment
- •Possible pregnancy or postpartum period
- •Inability or refusal to sign the consent form
结局指标
主要结局
Infarct Size (CMR)
时间窗: CMR will be done at least 3months after the myocardial infarction.
This measurement represents one of the two co-primary outcomes of the study. Infarct size will be quantified by cardiac magnetic resonance imaging (CMR) and expressed in grams. CMR will be performed at least 3 months after the myocardial infarction to minimize the influence of myocardial edema.
Global Longitudinal Strain (GLS)
时间窗: Within the first 5 days after acute myocardial infarction.
This measurement represents one of the two co-primary outcomes of the study. Left ventricular global longitudinal strain will be assessed by transthoracic echocardiography during hospitalization to evaluate myocardial systolic function.
次要结局
- Arrhythmia burden(First 24 hours after percutaneous coronary intervention)
- Safety Outcome - Number of participants with Cardiogenic shock(From admission until hospital discharge (up to 10 days).)
- Biomarkers of myocardial injury - Peak hs-Troponin I (ng/mL)(At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.)
- Safety Outcome - Number of participants with Hypotension(From admission until hospital discharge (up to 10 days).)
- Safety Outcome - Number of participants with Symptomatic bradycardia / conduction abnormalities(From admission until hospital discharge (up to 10 days).)
- Biomarkers of myocardial injury - Area Under the Curve for hs-Troponin I (ng·h/mL)(Baseline to 72 hours.)
- Safety Outcome - Number of participants with recurrence of myocardial infarction or angina(From admission until hospital discharge (up to 10 days).)
- Safety Outcome - Number of participants with new or worsened Heart Failure(From admission until hospital discharge (up to 10 days).)
- Safety Outcome - Number of participants with cardiovascular death (In-Hospital Cardiovascular Mortality)(From admission until hospital discharge (up to 10 days).)
- Biomarkers of myocardial injury - Area under the curve for Creatine phosphokinase (ng·h/mL)(Baseline to 72 hours.)
- Biomarkers of myocardial injury - Peak creatinine phosphokinase (U/L)(At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.)
研究者
Nikolaos Fragakis
Professor of Cardiology
Aristotle University Of Thessaloniki