protocolSection identificationModule nctId: NCT06376630, orgStudyIdInfo id: 298-2024, briefTitle: Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI, acronym: ESMO-VASCMI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2029-01-29, completionDateStruct date: 2030-01-29, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Myocardial Infarction, conditions: Coronary Stenosis, conditions: Coronary Microvascular Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 300 pts with MI are to be enrolled. Among them 100 pts with STEMI will be included into the substudy evaluating cardioprotective effects of early iv administration of esmolol. They will be randomized 1:1 by in arms receiving esmolol or no IV beta-blockers. In the esmolol arm the infusion will begin immediately on admission. 200 pts with MI and multivessel disease with non-IRA lesions of 50-85% diameter stenosis will be included into another substudy investigating coronary physiology. All patients will undergo PCI with IRA stenting. 50 stable patients will undergo invasive measurements of coronary physiology. Those will also undergo cardiac MRI. Other 150 pts will not undergo invasive measurements of coronary physiology during initial hospitalization. Pts in both groups will be hospitalized again in 30-40 days after MI. They will undergo stress SPECT or stress echocardiography. All patients will undergo a follow-up coronary angiography with invasive measurement of coronary physiology., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: envelopes, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Esmolol Hcl 10Mg/Ml Inj, outcomesModule primaryOutcomes measure: Composite of adverse cardiac outcomes, secondaryOutcomes measure: Degree of microvascular obstruction, secondaryOutcomes measure: Infarct size, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NMRCCardiologyRu, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Andrey Komarov, PhD, role: SUB_INVESTIGATOR, contacts name: Tatiana Sukhinina, PhD, role: SUB_INVESTIGATOR, contacts name: Mariy Terenicheva, PhD, role: SUB_INVESTIGATOR, contacts name: Olga Stukalova, PhD, role: SUB_INVESTIGATOR, contacts name: Sergey Ternovoy, Academic, role: SUB_INVESTIGATOR, contacts name: Goar Arutiunian, PhD, role: SUB_INVESTIGATOR, contacts name: Evgeniy Merkulov, PhD, role: SUB_INVESTIGATOR, contacts name: Viktor Shitov, MD, role: SUB_INVESTIGATOR, contacts name: Marina Saidova, PhD, role: SUB_INVESTIGATOR, contacts name: Aleksey Ansheles, PhD, role: SUB_INVESTIGATOR, contacts name: Vladimir Sergienko, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False