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Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI
Sponsor: China National Center for Cardiovascular Diseases
Summary
Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately one half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, namely microvascular dysfunction. Previous studies have shown that coronary microvascular damage significantly impacts the prognosis of patients with STEMI. Therefore, restoration of microvascular function is quite important during the PPCI procedures. Recent clinical trials found that nicorandil, a hybrid ATP-sensitive potassium channel opening agent, improved microvascular function, prevented no-reflow phenomenon, and had beneficial cardioprotective effects in patients receiving PPCI. However, there was a lack of evidence on the protective effects of nicorandil on microvascular function. The coronary angiography-derived IMR (AMR) is a novel wire-free technology developed for fast computation of IMR in patients undergoing coronary angiography, thereby enabling the quantification of coronary microcirculation of patients. This study is aimed to investigate the effects of nicorandil on microvascular dysfunction as evaluated by AMR in patients with STEMI.
Official title: Evaluating the Effects of Nicorandil on Microvascular Dysfunction in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-03-01
Completion Date
2027-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
nicorandil
In the nicorandil group, intracoronary nicorandil 3mg dissolved in 3ml saline was given within 30 seconds at two time points, one was when the guidewire or ballon passed the lesion and the blood flow was regained, and another was the time before the stent was implanted.
Saline (NaCl 0,9 %) (placebo)
In the control group, 3ml saline was given intracoronary through the guiding catheter within 30 seconds at the same time points in nicorandil group.