Impact of Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction

Официальное название

The Impact of Sympathetic Drive Control With Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction

Обзор

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.

Первичные конечные точки

• Infarct Size (CMR) [Срок оценки: CMR will be done at least 3months after the myocardial infarction.]
• Global Longitudinal Strain (GLS) [Срок оценки: Within the first 5 days after acute myocardial infarction.]

Вторичные конечные точки (11)

• Arrhythmia burden [Срок оценки: First 24 hours after percutaneous coronary intervention]
• Biomarkers of myocardial injury - Peak hs-Troponin I (ng/mL) [Срок оценки: At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.]
• Safety Outcome - Number of participants with Cardiogenic shock [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Safety Outcome - Number of participants with Symptomatic bradycardia / conduction abnormalities [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Safety Outcome - Number of participants with Hypotension [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Safety Outcome - Number of participants with recurrence of myocardial infarction or angina [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Safety Outcome - Number of participants with new or worsened Heart Failure [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Safety Outcome - Number of participants with cardiovascular death (In-Hospital Cardiovascular Mortality) [Срок оценки: From admission until hospital discharge (up to 10 days).]
• Biomarkers of myocardial injury - Area under the curve for Creatine phosphokinase (ng·h/mL) [Срок оценки: Baseline to 72 hours.]
• Biomarkers of myocardial injury - Area Under the Curve for hs-Troponin I (ng·h/mL) [Срок оценки: Baseline to 72 hours.]
• Biomarkers of myocardial injury - Peak creatinine phosphokinase (U/L) [Срок оценки: At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• Hippokration General Hospital of Thessaloniki — Thessaloniki

Публикации

• Nasoufidou A, Bantidos MG, Stachteas P, Moysidis DV, Mitsis A, Fyntanidou B, Kouskouras K, Karagiannidis E, Karamitsos T, Kassimis G, Fragakis N. The Role of Landiolol in Coronary Artery Disease: Insights into Acute Coronary Syndromes, Stable Coronary Artery Disease and Computed Tomography Coronary Angiography. J Clin Med. 2025 Jul 23;14(15):5216. doi: 10.3390/jcm14155216. PMID 40806838

Идентификаторы

NCT: NCT07293832 · 22/28-3-2023_5123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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