STEMIBLOCK-AMINCT07293832
Impact of Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction
An observational study of STEMI, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 13 Nov 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with STEMI presenting to Hippokration General Hospital of Thessaloniki will be evaluated for eligibility.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Hippokration General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 546 42
Athina Nasoufidou, MD, MSc, PhDc, (+30) 2313236344, athinanassi@gmail.com
Athina Nasoufidou, MD, MSc, PhDc
About this study
Official title: 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).
Read more
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
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous BB (receiving landiolol) or p.o. BB | STEMI patients receiving beta-blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within the first 5 days after acute myocardial infarction.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the diagnosis of STEMI, and subsequently at 1 hour, 24 hours, 48 hours, and 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start13 Nov 2024
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Fragakis, Aristotle University Of Thessaloniki
- Investigators
- Nikolaos Fragakis, Professor fo Cardiology, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293832
- Sponsor's protocol ID
- 22/28-3-2023_5123
- Acronym
- BLOCK-AMI
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40806838
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sympathetic Drive Control With Cardio-Selective Beta-Blockers on Infarct Size After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07293832
- Acronym / sponsor ID
- BLOCK-AMI / 22/28-3-2023_5123
- Conditions
- STEMI
- Keywords
- beta-blocker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous BB (receiving landiolol) or p.o. BB | – | –STEMI patients receiving beta-blocker |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with STEMI presenting to Hippokration General Hospital of Thessaloniki will be evaluated for eligibility.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infarct Size (CMR)
Time frame: CMR will be done at least 3months after the myocardial infarction.
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.
Global Longitudinal Strain (GLS)
Time frame: Within the first 5 days after acute myocardial infarction.
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.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 40806838Nasoufidou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaos Fragakis, Professor fo Cardiology, PhD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athina Nasoufidou, MD, MSc, PhDc ((+30) 2313236344, athinanassi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size (CMR) (time frame: CMR will be done at least 3months after the myocardial infarction.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07293832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.