Actively Recruiting
Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI
Led by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Updated on 2024-04-19
300
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed acute ST elevation myocardial infarction (type 1) within 8 hours of onset
- Treating physician's decision not to administer intravenous metoprolol before primary PCI due to high risk of complications
- Signed informed consent to participate
- Diagnosed myocardial infarction with completed PCI of infarct-related artery and multivessel coronary artery disease with 50-85% stenosis in non-infarct arteries
- Signed informed consent to participate
You will not qualify if you...
- Severe heart failure including pulmonary edema or cardiogenic shock
- Atrioventricular conduction abnormalities above first degree without pacemaker
- Sinus bradycardia with heart rate below 60 bpm
- Blood pressure below 100/60 mm Hg
- Asthma in exacerbation
- History of STEMI in infarct-related artery basin
- Clinically significant bleeding or hypovolemia
- Hypersensitivity to esmolol
- Pregnancy or breastfeeding
- Severe comorbidities affecting prognosis (e.g., advanced liver failure, active cancer)
- Contraindications to MRI (e.g., incompatible devices, metal fragments, claustrophobia, allergy to gadolinium)
- Severe dementia
- Chronic kidney disease stage 3b or worse (GFR below 45 mL/min/1.73 m2)
- History of coronary artery bypass grafting
- Non-infarct artery lesions less than 50% or above 85% stenosis, or left main coronary artery stenosis above 50%
- History or high risk of contrast-induced nephropathy
- Early post-infarction angina
- Complicated PCI or no-reflow phenomenon
- Thrombolysis for acute myocardial infarction
- ECG evidence of spontaneous reperfusion on admission
- Patient refusal to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
NMRCCardiologyRu
Moscow, Russia
Actively Recruiting
Research Team
M
Maria Terenicheva, MD
CONTACT
G
Goar Arutunian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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