NCT06376630: ESMO-VASCMI

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

Recruiting now NA Last updated 19 April 2024

What this trial tests

NA trial testing Esmolol Hcl 10Mg/Ml Inj in Myocardial Infarction in 300 participants. Currently enrolling.

Timeline

29 January 2024

Primary endpoint
29 January 2029

29 January 2030

Quick facts

Lead sponsor	National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	29 January 2024
Primary completion	29 January 2029
Estimated completion	29 January 2030
Sites	1 location across Russia

Drugs / interventions tested

• Esmolol Hcl 10Mg/Ml Inj — full drug profile →

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Coronary Stenosis — all drugs for Coronary Stenosis →
• Coronary Microvascular Dysfunction — all drugs for Coronary Microvascular Dysfunction →

Sponsor

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

Who can join

18 and older, any sex, with Myocardial Infarction or Coronary Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.