ST Segment Elevation Myocardial Infarction (STEMI)NCT06967194
Early Beta Blocker Administration in STEMI Patients With SCAI B Status
A study testing Metoprolol (MET) and Plcacebo in people with ST Segment Elevation Myocardial Infarction (STEMI) and Cardiogenic Shock Post Myocardial Infarction, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study is looking at how a medication called beta-blockers (metoprolol) affects patients with a heart attack (STEMI) who are in the cardiac intensive care unit. When patients are admitted to the unit, they will be randomly placed in one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock Post Myocardial Infarction
- What is being tested?
- Metoprolol (MET) and Plcacebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 21 May 2025to Jun 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ST-segment elevation myocardial infarction (STEMI) confirmed by ECG, clinical signs, and coronary catheterization.
- Post-catheterization patients classified as SCAI B upon admission to the unit, defined by the presence of tachycardia and/or hypotension without signs of hypoperfusion (i.e., normal lactate levels, normal capillary refill, preserved mental status, and adequate urine output >0.5 mL/kg/hour).
- Age 18 years or older.
- Mentally competent to provide informed consent, understand the study procedures, and comply with medical recommendations.
Who cannot join
- Pregnancy.
- Inability to provide informed consent.
- Evidence of pulmonary edema.
- Bradycardia (heart rate <60 beats per minute).
- PR interval >240 milliseconds.
- Second- or third-degree atrioventricular (AV) block.
- Active asthma.
- Known hypersensitivity to metoprolol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yishay Szekely, MD contact
About this study
Official title: Early Beta-Blocker Administration in Patients With ST Segment Elevation Myocardial Infraction and SCAI B Status
This study is looking at how a medication called beta-blockers (metoprolol) affects patients with a heart attack (STEMI) who are in the cardiac intensive care unit.
When patients are admitted to the unit, they will be randomly placed in one of two groups. One group will get the metoprolol medication, and the other will receive a placebo (a harmless pill that looks like the real medication). All other treatments will be the same for both groups.
Read more
During the study, which is 72 hours long, patients will be monitored for blood pressure, heart rate, and lactate levels alterations.
The main goal is to see if the medication helps improve patients condition or prevent it from getting worse. patients safety is a top priority, and if needed, the doctors can stop the study at any time if there are concerns.
Read the detailed description
A prospective, randomized, double-blind cohort study will be conducted on patients with STEMI who are hospitalized in the cardiac intensive care unit and classified as SCAI B at the time of admission by the attending physician. Patients will be identified upon admission to the unit and randomized into two arms - a control group and an intervention group. Randomization will be performed using sealed envelopes. A block randomization model will be used based on LVEF estimation of >40% or ≤40%.
In the intervention group, patients will receive standard beta-blocker treatment, specifically low-dose metoprolol at 25 mg twice daily. In the control group, patients will receive a placebo. All other standard treatments will be identical between the two study groups, in accordance with the unit's treatment protocol and the clinical status of the patients.
As an integral part of this treatment, patients will be continuously monitored for parameters including blood pressure, heart rhythm, and blood lactate levels.
The treatment duration under this protocol will be 72 hours or until the occurrence of the primary outcome, whichever comes first. The primary outcome is defined as progression of the patient's condition to SCAI C, according to accepted criteria, including an increase in lactate levels, a decrease in urine output, or a change in mental status. Per guidelines, every 24 hours, investigators will re-evaluate each patient. If they meet current criteria for beta-blocker administration (SCAI A status and no contraindications), the study drug will be terminated and active metoprolol will be prescribed.
To ensure patient safety, the treating staff will have the option to request unblinding of the patient's allocation at any time. Additionally, after the enrollment of 100 patients (or after one year, whichever comes first), an interim analysis of the data will be conducted to ensure the study remains within established safety parameters.
An echocardiogram and follow-up visit will be performed at 30 days.
- Conditions
- ST Segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock Post Myocardial Infarction
- Being tested
- Metoprolol (MET), Plcacebo
- Keywords
- acute MI, stemi, beta blockers
- 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.
Metoprolol (MET)Drug
Also called metoprolol 25mg
Administration of metoprolol 25 mg twice daily
PlcaceboDrug
Also called placebo
Administration of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients treated with Metoprolol 25mg Receives: Drug: Metoprolol (MET) |
| Placebo | Placebo comparator | Patients treated with matching placebo Receives: Drug: Plcacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients progressed from SCAI B to SCAI C
number of patients who progressed from SCAI B to SCAI C as measured by - Serum lactate levels > mmol/L urinary output > 0.5 ml/kg/hour slow capillary filling Change in mental status
Measured: 3 days from enrollment
Secondary outcomes (5)
Rate of in-hospital mortality
The mortality rate of patients during index admission
Measured: during index admission - expected up to 7 days
Need for Mechanical ventilation
The rate of patients that will require mechanical ventilation
Measured: During index admission - expected up to 7 days
Minor adverse events
minor events including tachyarrhythmia, bradyarrhythmia, AV blocks
Measured: 3 days from enrollment
Hospitalizion duration
Time of index hospitalization
Measured: During index admission - expected up to 7 days
Ejection fraction at 30 days
Ejection fraction as measured by echocardiography at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start21 May 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ST Segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, double-blind cohort study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yishay Szekely, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967194
- Sponsor's protocol ID
- TLV-0011-25
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy of participants
Publications
Pizarro G, Fernandez-Friera L, Fuster V, Fernandez-Jimenez R, Garcia-Ruiz JM, Garcia-Alvarez A, Mateos A, Barreiro MV, Escalera N, Rodriguez MD, de Miguel A, Garcia-Lunar I, Parra-Fuertes JJ, Sanchez-Gonzalez J, Pardillos L, Nieto B, Jimenez A, Abejon R, Bastante T, Martinez de Vega V, Cabrera JA, Lopez-Melgar B, Guzman G, Garcia-Prieto J, Mirelis JG, Zamorano JL, Albarran A, Goicolea J, Escaned J, Pocock S, Iniguez A, Fernandez-Ortiz A, Sanchez-Brunete V, Macaya C, Ibanez B. Long-term benefit of early pre-reperfusion metoprolol administration in patients with acute myocardial infarction: results from the METOCARD-CNIC trial (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction). J Am Coll Cardiol. 2014 Jun 10;63(22):2356-62. doi: 10.1016/j.jacc.2014.03.014. Epub 2014 Mar 30.
PubMed 24694530Roolvink V, Ibanez B, Ottervanger JP, Pizarro G, van Royen N, Mateos A, Dambrink JE, Escalera N, Lipsic E, Albarran A, Fernandez-Ortiz A, Fernandez-Aviles F, Goicolea J, Botas J, Remkes W, Hernandez-Jaras V, Kedhi E, Zamorano JL, Navarro F, Alfonso F, Garcia-Lledo A, Alonso J, van Leeuwen M, Nijveldt R, Postma S, Kolkman E, Gosselink M, de Smet B, Rasoul S, Piek JJ, Fuster V, van 't Hof AWJ; EARLY-BAMI Investigators. Early Intravenous Beta-Blockers in Patients With ST-Segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Jun 14;67(23):2705-2715. doi: 10.1016/j.jacc.2016.03.522. Epub 2016 Apr 3.
PubMed 27050189Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Beta-Blocker Administration in Patients With ST Segment Elevation Myocardial Infraction and SCAI B Status
- ClinicalTrials.gov ID
- NCT06967194
- Acronym / sponsor ID
- TLV-0011-25
- Conditions
- ST Segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock Post Myocardial Infarction
- Keywords
- acute MI, stemi, beta blockers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 21 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 May 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.
This study is looking at how a medication called beta-blockers (metoprolol) affects patients with a heart attack (STEMI) who are in the cardiac intensive care unit.
When patients are admitted to the unit, they will be randomly placed in one of two groups. One group will get the metoprolol medication, and the other will receive a placebo (a harmless pill that looks like the real medication). All other treatments will be the same for both groups.
During the study, which is 72 hours long, patients will be monitored for blood pressure, heart rate, and lactate levels alterations.
The main goal is to see if the medication helps improve patients condition or prevent it from getting worse. patients safety is a top priority, and if needed, the doctors can stop the study at any time if there are concerns.
Detailed description
A prospective, randomized, double-blind cohort study will be conducted on patients with STEMI who are hospitalized in the cardiac intensive care unit and classified as SCAI B at the time of admission by the attending physician. Patients will be identified upon admission to the unit and randomized into two arms - a control group and an intervention group. Randomization will be performed using sealed envelopes. A block randomization model will be used based on LVEF estimation of >40% or ≤40%.
In the intervention group, patients will receive standard beta-blocker treatment, specifically low-dose metoprolol at 25 mg twice daily. In the control group, patients will receive a placebo. All other standard treatments will be identical between the two study groups, in accordance with the unit's treatment protocol and the clinical status of the patients.
As an integral part of this treatment, patients will be continuously monitored for parameters including blood pressure, heart rhythm, and blood lactate levels.
The treatment duration under this protocol will be 72 hours or until the occurrence of the primary outcome, whichever comes first. The primary outcome is defined as progression of the patient's condition to SCAI C, according to accepted criteria, including an increase in lactate levels, a decrease in urine output, or a change in mental status. Per guidelines, every 24 hours, investigators will re-evaluate each patient. If they meet current criteria for beta-blocker administration (SCAI A status and no contraindications), the study drug will be terminated and active metoprolol will be prescribed.
To ensure patient safety, the treating staff will have the option to request unblinding of the patient's allocation at any time. Additionally, after the enrollment of 100 patients (or after one year, whichever comes first), an interim analysis of the data will be conducted to ensure the study remains within established safety parameters.
An echocardiogram and follow-up visit will be performed at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, double-blind cohort study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Metoprolol (MET)Patients treated with Metoprolol 25mg |
| Placebo | Placebo comparator | Drug: PlcaceboPatients treated with matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of ST-segment elevation myocardial infarction (STEMI) confirmed by ECG, clinical signs, and coronary catheterization.
- Post-catheterization patients classified as SCAI B upon admission to the unit, defined by the presence of tachycardia and/or hypotension without signs of hypoperfusion (i.e., normal lactate levels, normal capillary refill, preserved mental status, and adequate urine output >0.5 mL/kg/hour).
- Age 18 years or older.
- Mentally competent to provide informed consent, understand the study procedures, and comply with medical recommendations.
Key exclusion criteria (8 listed)
- Pregnancy.
- Inability to provide informed consent.
- Evidence of pulmonary edema.
- Bradycardia (heart rate <60 beats per minute).
- PR interval >240 milliseconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol (MET)Also: metoprolol 25mgAdministration of metoprolol 25 mg twice daily | Drug | Intervention |
| PlcaceboAlso: placeboAdministration of matching placebo | Drug | Placebo |
Primary outcome
Number of patients progressed from SCAI B to SCAI C
Time frame: 3 days from enrollment
number of patients who progressed from SCAI B to SCAI C as measured by - Serum lactate levels > mmol/L urinary output > 0.5 ml/kg/hour slow capillary filling Change in mental status
5 secondary outcomes
Rate of in-hospital mortality
Time frame: during index admission - expected up to 7 days
Need for Mechanical ventilation
Time frame: During index admission - expected up to 7 days
Minor adverse events
Time frame: 3 days from enrollment
Hospitalizion duration
Time frame: During index admission - expected up to 7 days
Ejection fraction at 30 days
Time frame: 30 days
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 28 May 2025.
- Results publication: PubMed 24694530Pizarro G, Fernandez-Friera L, Fuster V, Fernandez-Jimenez R, Garcia-Ruiz JM, Garcia-Alvarez A, Mateos A, Barreiro MV, Escalera N, Rodriguez MD, de Miguel A, Garcia-Lunar I, Parra-Fuertes JJ, Sanchez-Gonzalez J, Pardillos L, Nieto B, Jimenez A, Abejon R, Bastante T, Martinez de Vega V, Cabrera JA, Lopez-Melgar B, Guzman G, Garcia-Prieto J, Mirelis JG, Zamorano JL, Albarran A, Goicolea J, Escaned J, Pocock S, Iniguez A, Fernandez-Ortiz A, Sanchez-Brunete V, Macaya C, Ibanez B. Long-term benefit of early pre-reperfusion metoprolol administration in patients with acute myocardial infarction: results from the METOCARD-CNIC trial (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction). J Am Coll Cardiol. 2014 Jun 10;63(22):2356-62. doi: 10.1016/j.jacc.2014.03.014. Epub 2014 Mar 30.
- Results publication: PubMed 27050189Roolvink V, Ibanez B, Ottervanger JP, Pizarro G, van Royen N, Mateos A, Dambrink JE, Escalera N, Lipsic E, Albarran A, Fernandez-Ortiz A, Fernandez-Aviles F, Goicolea J, Botas J, Remkes W, Hernandez-Jaras V, Kedhi E, Zamorano JL, Navarro F, Alfonso F, Garcia-Lledo A, Alonso J, van Leeuwen M, Nijveldt R, Postma S, Kolkman E, Gosselink M, de Smet B, Rasoul S, Piek JJ, Fuster V, van 't Hof AWJ; EARLY-BAMI Investigators. Early Intravenous Beta-Blockers in Patients With ST-Segment Elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Jun 14;67(23):2705-2715. doi: 10.1016/j.jacc.2016.03.522. Epub 2016 Apr 3.
- Results publication: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Individual participant dataSharing planned: No. Privacy of participants
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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.
Yishay Szekely, MD contact
Yishay Szekely, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol (MET) and Plcacebo in people with ST Segment Elevation Myocardial Infarction (STEMI) and Cardiogenic Shock Post Myocardial Infarction, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 inclusion and 8 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 28 May 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 Israel. 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. Some participants in this study may receive a placebo. 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 Shir Frydman, MD (0544267898, shirfrydman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients progressed from SCAI B to SCAI C (time frame: 3 days from enrollment). 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 NCT06967194, which also lists 3 linked publications.
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 28 May 2025.