Impact of Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction (BLOCK-AMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Athina Nasoufidou, MD, MSc, PhDc; Phone Number: (+30) 2313236344; Email: athinanassi@gmail.com

Study Locations

• Greece
  • Thessaloniki
    • Thessaloniki, Thessaloniki, Greece, 546 42
      • Recruiting
      • Hippokration General Hospital of Thessaloniki
      • Contact: Athina Nasoufidou, MD, MSc, PhDc; Phone Number: (+30) 2313236344; Email: athinanassi@gmail.com
      • Sub-Investigator: Athina Nasoufidou, MD, MSc, PhDc
      • Principal Investigator: Nikolaos Fragakis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intravenous BB (receiving landiolol) or p.o. BB; STEMI patients receiving beta-blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia burden	Arrhythmia burden will be quantified from continuous telemetry monitoring during the first 24 hours after PCI. The arrhythmia burden will be expressed as a composite index integrating the following components obtained from the same monitoring period: frequency of non-sustained ventricular tachycardia (NSVT) episodes (≥3 consecutive ventricular beats lasting <30 seconds),; frequency of ventricular tachycardia (VT) episodes (≥3 consecutive ventricular beats lasting ≥30 seconds),; cumulative duration (in seconds) of all NSVT/VT episodes, and; total number of ventricular ectopic beats recorded during NSVT/VT events. All components will be analyzed collectively as quantitative descriptors of the overall arrhythmia burden.	First 24 hours after percutaneous coronary intervention
Biomarkers of myocardial injury - Peak hs-Troponin I (ng/mL)	Serial measurements of hs-troponin concentrations will be performed. Hs-troponin will be measured in ng/ml. Reported summary measure will include the peak value from the scheduled samples. Samples are obtained as part of routine clinical care and analyzed by the site laboratory.	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	Number of participants who develop cardiogenic shock during hospitalization, defined as sustained hypotension accompanied by clinical or laboratory evidence of end-organ hypoperfusion and requiring initiation of inotropic support.	From admission until hospital discharge (up to 10 days).
Safety Outcome - Number of participants with Symptomatic bradycardia / conduction abnormalities	Number of participants with new or worsened symptomatic bradycardia (heart rate <55 bpm with symptoms) or new conduction disturbances (e.g., new second- or third-degree AV block), documented by ECG or telemetry.	From admission until hospital discharge (up to 10 days).
Safety Outcome - Number of participants with Hypotension	Number of participants who develop hypotension defined as systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg, as recorded in observations.	From admission until hospital discharge (up to 10 days).
Safety Outcome - Number of participants with recurrence of myocardial infarction or angina	Number of participants with documented recurrent myocardial infarction or recurrent ischemic chest pain (angina) requiring medical evaluation or intervention.	From admission until hospital discharge (up to 10 days).
Safety Outcome - Number of participants with new or worsened Heart Failure	Number of participants who develop sudden worsening of chronic heart failure (HF) or new-onset HF with congestion requiring therapy or prolongation of hospital stay.	From admission until hospital discharge (up to 10 days).
Safety Outcome - Number of participants with cardiovascular death (In-Hospital Cardiovascular Mortality)	Number of participants with cardiovascular death occurring during the hospitalization, defined as death resulting from acute myocardial infarction, arrhythmia, cardiogenic shock, progressive heart failure, sudden cardiac death, death due to cardiovascular procedures (e.g., PCI complications), or death from other confirmed cardiovascular pathology such as aortic dissection, acute valvular failure, or pulmonary embolism.	From admission until hospital discharge (up to 10 days).
Biomarkers of myocardial injury - Area under the curve for Creatine phosphokinase (ng·h/mL)	Area under the curve for creatinine phosphokinase (CPK) calculated using the trapezoidal rule from serial CPK measurements.	Baseline to 72 hours.
Biomarkers of myocardial injury - Area Under the Curve for hs-Troponin I (ng·h/mL)	Area under the curve calculated using the trapezoidal rule from serial hs-Troponin I measurements. Samples are obtained as part of routine clinical care and analyzed by the site laboratory.	Baseline to 72 hours.
Biomarkers of myocardial injury - Peak creatinine phosphokinase (U/L)	Serial measurements of creatinine phosphokinase (CPK) concentrations will be performed. CPK will be measured in U/L. Reported summary measure will include the peak value from the scheduled samples. Samples are obtained as part of routine clinical care and analyzed by the site laboratory.	At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Nikolaos Fragakis, Professor fo Cardiology, PhD, Aristotle University Of Thessaloniki

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: beta-blocker
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 22/28-3-2023_5123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No