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

Official title

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

Overview

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.

Primary outcome measures

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

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Greece · 1 center

• Hippokration General Hospital of Thessaloniki — Thessaloniki

Publications

• 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

Identifiers

NCT: NCT07293832 · 22/28-3-2023_5123

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗