Tel Aviv Sourasky Medical center
Tel Aviv, Israel
Location status: Recruiting
NCT Number: NCT06967194
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tel Aviv, Israel
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of metoprolol 25 mg twice daily
Other names: metoprolol 25mg
Administration of matching placebo
Other names: placebo
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
Time frame: during index admission - expected up to 7 days
The mortality rate of patients during index admission
Time frame: During index admission - expected up to 7 days
The rate of patients that will require mechanical ventilation
Time frame: 3 days from enrollment
minor events including tachyarrhythmia, bradyarrhythmia, AV blocks
Time frame: During index admission - expected up to 7 days
Time of index hospitalization
Time frame: 30 days
Ejection fraction as measured by echocardiography at 30 days
Contact information is provided by the study sponsor or research team.
Tel-Aviv Sourasky Medical Center
Other Gov
Early Beta-Blocker Administration in Patients With ST Segment Elevation Myocardial Infraction and SCAI B Status
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07072858
Artificial Intelligence (AI), Cardiovascular Diseases
Beijing, China
View Trial DetailsNCT06847568
Cardiovascular Diseases, Heart Diseases
Cairo, Egypt
View Trial DetailsNCT06794801
Cardiovascular Diseases, Heart Diseases
Lanzhou, Gansu, China
View Trial DetailsNCT06661018
Cardiovascular Diseases, Coenzyme Q10
Semarang, Central Java, Indonesia
View Trial Details