Evaluating the effects of esmolol in patients with heart attacks

Study of Microvascular Dysfunction, Coronary Flow Reserve and Cardioprotective Effect of Early Intravenously Administration of Esmolol in Patients With Myocardial Infarction

This study tests if giving esmolol early to people having a heart attack can help protect their heart and improve blood flow compared to those who don’t get the treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation (Government)
• Locations: 1 site (Moscow)
• Trial ID: NCT06376630 on ClinicalTrials.gov

What this trial studies

This study aims to assess the clinical and prognostic significance of microvascular dysfunction and coronary flow reserve in patients experiencing acute ST-segment elevation myocardial infarction (MI). It involves an open randomized trial where patients will receive early intravenous administration of esmolol, compared to a control group that does not receive this treatment. The study will also utilize cardiac MRI to evaluate microvascular obstruction and infarct size, alongside measuring coronary physiology parameters over time. The goal is to determine the cardioprotective effects of esmolol in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with acute ST elevation myocardial infarction within the first 8 hours of onset who are at high risk for complications from other treatments.

Not a fit: Patients with severe heart failure, significant conduction abnormalities, or those who are currently experiencing asthma exacerbations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with myocardial infarction by providing a new cardioprotective strategy.

How similar studies have performed: While the specific approach of using esmolol in this context may be novel, similar studies have shown promising results in evaluating cardioprotective strategies in myocardial infarction.

Eligibility criteria

Substudy evaluating cardioprotective effects of early iv administration of esmolol

Inclusion Criteria:

* Diagnosed acute ST elevation MI, type 1, within the first 8 hours of disease onset;
* Treating physician's decision not to administer metoprolol intravenously prior to primary PCI due to a high risk of complications (BP \< 120/80 mm Hg at baseline examination, moderate evidence of heart failure (Killip 2) or a risk of its development (LV EF ≤ 30%), first degree AV block with PQ ≥ 0.25 ms, history of asthma or severe COPD etc.)
* Signed Informed Consent to participate in the study

Exclusion Criteria:

* severe heart failure (pulmonary edema; SCAI В-Е cardiogenic shock);
* atrioventricular conduction abnormality higher than first degree, without a pacemaker;
* sinus bradycardia with the heart rate of \< 60 bpm;
* BP \< 100/60 mm Hg.;
* asthma in exacerbation;
* history of a STEMI in the IRA basin;
* clinically significant bleeding or hypovolemia;
* hypersensitivity to esmolol;
* pregnancy or lactation;
* known severe comorbidities independently affecting prognosis (Child Pugh class C liver failure, active malignancies etc.);
* contraindications to MRI (MR-incompatible pacemaker/implanted cardioverter-defibrillator, cochlear implants, clips on brain vessels, foreign metal objects - bullets, intraorbital metal fragments, insulin pumps, body weight above 150 kg, history of allergies to gadolinium, claustrophobia);
* severe dementia;
* known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.);
* complicated PCI, "no reflow" phenomenon on follow-up coronary angiography;
* thrombolysis for AMI;
* ECG evidence of spontaneous reperfusion on admission;
* patient's refusal from participation in the study.

Substudy investigating coronary physiology

Inclusion Criteria:

* Diagnosed MI, completed PCI for the IRA and multivessel Coronary Artery Disease with diameter stenosis of 50-85% in non-IRA.
* Signed Informed Consent to participate in the study

Exclusion criteria:

* History of coronary artery bypass grafting surgery;
* Non-IRA lesions resulting in diameter stenosis of below 50% and above 85%, main left coronary artery (LCA) stenosis above 50%;
* Chronic kidney disease stage 3b or above (glomerular filtration rate below 45 mL/min/m2 according to the CKD-EPI equation);
* History of a contrast-induced nephropathy (CIN) or a high CIN risk (calculated using the Mehran score);
* History of allergies to iodine-containing medications;
* Pregnancy or lactation;
* Left ventricle ejection fraction ≤ 30%;
* Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.);
* Early post-infarction angina;
* Severe dementia;
* Patient's refusal from participation in the study.

Where this trial is running

Moscow

• NMRCCardiologyRu — Moscow, Russia (Recruiting)

Study contacts

• Principal investigator: Dmitry Pevzner, MD — National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Study coordinator: Maria Terenicheva, MD

Conditions Myocardial Infarction; Coronary Stenosis; Coronary Microvascular Dysfunction