NCT06376630Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 19 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 300 (estimated)
First submitted: 10 Apr 2024
Start date: 29 Jan 2024
Primary completion date: 29 Jan 2029
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Diseases: Coronary artery disease
NCT number: NCT06376630

What you commit to

Study type: Interventional
Planned participants: 300
From 29 Jan 2024 to the primary completion date, 29 Jan 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

severe heart failure (pulmonary edema; SCAI В-Е cardiogenic shock);
sinus bradycardia with the heart rate of \< 60 bpm;
history of a STEMI in the IRA basin;
clinically significant bleeding or hypovolemia;
hypersensitivity to esmolol;
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.);
History of coronary artery bypass grafting surgery;
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;
Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.);
Early post-infarction angina;
Severe dementia;

Lab values

Left ventricle ejection fraction ≤ 30%;

Other

atrioventricular conduction abnormality higher than first degree, without a pacemaker;
BP \< 100/60 mm Hg.;
asthma in exacerbation;
pregnancy or lactation;
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
Non-IRA lesions resulting in diameter stenosis of below 50% and above 85%, main left coronary artery (LCA) stenosis above 50%;
Pregnancy or lactation;
Patient's refusal from participation in the study.

Who the study is looking for

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
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

Criteria the registry did not label

Substudy evaluating cardioprotective effects of early iv administration of esmolol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
NMRCCardiologyRu Coordinator of this site? Confirm its status	Moscow	Russia	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.