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RECRUITING

NCT06376630

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

Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

View on ClinicalTrials.gov

Summary

Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction. First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement. Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection. Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \> 12 months post-infarction. Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-01-29

Completion Date

2030-01-29

Last Updated

2024-04-19

Healthy Volunteers

Conditions

Myocardial Infarction Coronary Stenosis Coronary Microvascular Dysfunction

Interventions

DRUG

Esmolol Hcl 10Mg/Ml Inj

the loading dose of 500 mkg/kg for 1 minute, followed by the initial rate of 50 mkg/kg/min. Individual titration depending on the desired hemodynamical effect (to the heart rate of 60 bpm or to the maximum tolerated dose maintaining stable hemodynamics) every 5-15 minutes (the maximum allowed rate of administration is 300 mkg/kg/min) for 6 hours. Thereafter patients in both treatment arms - the IV esmolol arm and the placebo arm, will be administered oral β-adrenergic blockers, if decided so by the treating physician and unless contraindicated.

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.

Locations (1)

NMRCCardiologyRu

Moscow, Russia