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Updated: Jun 13, 2026
Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Inhibition of late sodium current (INa) to prevent coronary MICROvascular dysfunction in patients presenting with
Luigi Di Serafino1, Luca Ciaramella1, Salvatore De Rosa2
1Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Insights
This study investigates if ranolazine can improve coronary microvascular function after heart attacks (STEMI). Early ranolazine treatment shows potential for favorably modulating microvascular function post-STEMI.
Area of Science:
- Cardiology
- Cardiovascular Research
- Pharmacology
Background:
- Residual coronary microvascular dysfunction (CMD) is a common complication after ST-elevation myocardial infarction (STEMI) despite successful percutaneous coronary intervention (PCI).
- CMD can lead to ongoing ischemia and impaired heart recovery post-STEMI.
- The INaMICRON trial investigates early inhibition of the late INa current as a potential therapeutic strategy.
Purpose of the Study:
- To test the hypothesis that early ranolazine administration favorably modulates microvascular function in the early post-infarction phase.
- To assess the feasibility and magnitude of microvascular modulation with ranolazine post-STEMI.
- To inform the design of future outcome-oriented studies and precision medicine approaches for post-MI care.
Main Methods:
- A prospective, multicenter, randomized, open-label phase IIb trial (INaMICRON) in 100 adults with STEMI treated with primary PCI.
- Participants randomized to standard therapy plus ranolazine or standard therapy alone.
- Coronary microvascular function assessed via IMR/angioIMR, peripheral endothelial function (EndoPAT), cardiac MRI (CMR), and multi-omics analyses.
Main Results:
- The study is designed to estimate the magnitude of microvascular modulation in the ranolazine group compared to the control group.
- Analyses will compare between-group differences in coronary and peripheral microvascular function.
- Exploration of correlations between microvascular function and multi-omics data.
Conclusions:
- The trial will provide feasibility data on early ranolazine use post-STEMI.
- It will estimate the potential of ranolazine to modulate microvascular function.
- Findings will guide larger studies on ranolazine for improving post-MI recovery.
Introduction:
Residual coronary microvascular dysfunction (CMD) is common after STEMI despite successful primary PCI and may contribute to ongoing ischemia and impaired recovery. INaMICRON will test the hypothesis that early late INa current inhibition with ranolazine, added to guideline-directed medical therapy, favorably modulates microvascular function during the early post-infarction phase.
Methods And Results:
INaMICRON is a prospective, multicenter, randomized (1:1), open-label phase IIb trial enrolling adults with STEMI treated with successful primary PCI and at least one significant non-culprit lesion suitable for staged PCI. Participants will be randomized to standard therapy plus ranolazine (500 mg bid for 7 days, then 750 mg bid up to 42 ± 7 days) or standard therapy alone. Coronary microvascular function will be assessed using IMR and/or angioIMR in the culprit vessel after primary PCI (baseline) and during staged PCI (follow-up); non-culprit vessel physiology will also be assessed during the staged procedure. Complementary evaluations include peripheral endothelial function testing (EndoPAT), a single CMR at 42 ± 7 days, and paired blood sampling for translational multi-omics analyses. The planned sample size is 100 patients (50 per group), and analyses will compare between-group differences in physiology and related measures and explore predefined correlations. The study is designed to estimate the magnitude of microvascular modulation in the experimental group.
Conclusions:
This trial will provide feasibility data and an estimate of the magnitude of microvascular modulation achievable with early ranolazine after STEMI, informing the design of larger outcome-oriented studies and future precision approaches to post-MI care.
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