NCT06967194

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
May 2025Jun 2027

First Submitted

Initial submission to the registry

April 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

April 28, 2025

Last Update Submit

May 21, 2025

Conditions

ST Segment Elevation Myocardial Infarction (STEMI)Cardiogenic Shock Post Myocardial Infarction

Keywords

acute MIstemibeta blockers

Outcome Measures

Primary Outcomes (1)

  • 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

    3 days from enrollment

Secondary Outcomes (5)

  • Rate of in-hospital mortality

    during index admission - expected up to 7 days

  • Need for Mechanical ventilation

    During index admission - expected up to 7 days

  • Minor adverse events

    3 days from enrollment

  • Hospitalizion duration

    During index admission - expected up to 7 days

  • Ejection fraction at 30 days

    30 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients treated with Metoprolol 25mg

Drug: Metoprolol (MET)

Placebo

PLACEBO COMPARATOR

Patients treated with matching placebo

Drug: Plcacebo

Interventions

Metoprolol (MET)DRUG

Administration of metoprolol 25 mg twice daily

Also known as: metoprolol 25mg
Intervention
PlcaceboDRUG

Administration of matching placebo

Also known as: placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical center

Tel Aviv, Israel

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24694530BACKGROUND

  • Roolvink 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.

    PMID: 27050189BACKGROUND

  • Byrne 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.

    PMID: 37622654BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Yishay Szekely, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shir Frydman, MD

CONTACT

0544267898shirfrydman@gmail.com

Yishay Szekely, MD

CONTACT

yishay.szekely@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, randomized, double-blind cohort study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 13, 2025

Study Start

May 21, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Privacy of participants

Locations

IL(1)