Evaluating the effects of esmolol in patients with heart attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: starcad@bk.ru
• Phone: 5874134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.