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

NCT07293832 | Recruiting

• 1 other identifier: 22/28-3-2023_5123
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI

Keywords

beta-blocker

Outcome Measures

Primary Outcomes (2)

• Infarct Size (CMR)

  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.

  CMR will be done at least 3months after the myocardial infarction.

• Global Longitudinal Strain (GLS)

  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.

  Within the first 5 days after acute myocardial infarction.

Secondary Outcomes (11)

• Arrhythmia burden

  First 24 hours after percutaneous coronary intervention

• 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 Cardiogenic shock

  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).

• Safety Outcome - Number of participants with Hypotension

  From admission until hospital discharge (up to 10 days).

Study Arms (1)

Intravenous BB (receiving landiolol) or p.o. BB

STEMI patients receiving beta-blocker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with STEMI presenting to Hippokration General Hospital of Thessaloniki will be evaluated for eligibility.

You may qualify if:

• 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

You may not qualify if:

• 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
• lead electrocardiogram with PR interval \>200 milliseconds
• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hippokration General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 546 42, Greece

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nikolaos Fragakis, Professor fo Cardiology, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athina Nasoufidou, MD, MSc, PhDc

CONTACT

(+30) 2313236344; athinanassi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 19, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

GR (1)