Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI

Launched by NATIONAL MEDICAL RESEARCH CENTER FOR CARDIOLOGY, MINISTRY OF HEALTH OF RUSSIAN FEDERATION · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called esmolol in patients who have experienced a heart attack, specifically those with a type of heart attack known as ST-segment elevation myocardial infarction (STEMI). The study aims to determine how well esmolol helps protect the heart and improve blood flow in patients who cannot receive another medication called metoprolol due to potential risks. The researchers will compare patients who receive esmolol to those who do not, looking at outcomes like heart function and the size of the heart injury using MRI scans.

To be eligible for the trial, participants must be diagnosed with an acute STEMI within the first 8 hours of onset and have certain health conditions that make using metoprolol risky. They will need to provide informed consent to participate. Throughout the study, participants can expect close monitoring of their heart health and may undergo additional testing to assess blood flow in the heart over time. This trial is important because it could lead to better treatments for patients who suffer heart attacks, helping to improve their long-term health outcomes.

Gender

ALL

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.