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

NCT ID: NCT07293832

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-13

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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STEMI

Keywords

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beta-blocker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

STEMI patients receiving beta-blocker

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Fragakis

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolaos Fragakis, Professor fo Cardiology, PhD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University Of Thessaloniki

Locations

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Hippokration General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Athina Nasoufidou, MD, MSc, PhDc

Role: CONTACT

Phone: (+30) 2313236344

Email: [email protected]

Facility Contacts

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Athina Nasoufidou, MD, MSc, PhDc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 40806838 (View on PubMed)

Other Identifiers

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22/28-3-2023_5123

Identifier Type: -

Identifier Source: org_study_id