Impact of Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction
ConditionSTEMI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAristotle University Of Thessaloniki
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All patients diagnosed with STEMI presenting to Hippokration General Hospital of Thessaloniki will be evaluated for eligibility.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Intravenous BB (receiving landiolol) or p.o. BB
Trial outcomes
Primary outcomes
1
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.
Time frame
CMR will be done at least 3months after the myocardial infarction.2
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.
Time frame
Within the first 5 days after acute myocardial infarction.Secondary outcomes
1
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.
Time frame
First 24 hours after percutaneous coronary intervention2
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.
Time frame
At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.3
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.
Time frame
From admission until hospital discharge (up to 10 days).4
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.
Time frame
From admission until hospital discharge (up to 10 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov