About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-80
Diagnosis of STEMI and indicating for primary PCI
Diagnostic coronary angiography showed definite culprit vessel and primary PCI was planned to treat the culprit vessel.
Reference vessel diameter of culprit vessel was greater than 2.0 mm
Disqualifiers
Acute in- stent thrombosis or in-stent stenosis lesions of culprit vessel.
Balloon angioplasty rather than stent was planned for the culprit vessel.
Allergic to nicorandil or systolic arterial pressure was less than 85mmHg before procedure
Vessel with twisted shape that was unable to be measured using AMR
Trial design
Parallel
Treatments tested in this trial
nicorandil
DrugIn 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)
DrugIn the control group, 3ml saline was given intracoronary through the guiding catheter within 30 seconds at the same time points in nicorandil group.
Treatment groups
Trial outcomes
Primary outcomes
The value of post-PCI AMR
AMR was obtained by analyzing the last angiography video of culprit vessel after procedure. AMR was analyzed by sophisticated technicians who were unaware of the group division.
Secondary outcomes
Prevalence of slow flow or no-flow during procedure
ST-segment resolution two hours after primary PCI
Analyze the elevated leads of EKG two hours after primary PCI
In-hospital peak troponin level
Prevalence of hypotension during procedure
Prevalence of hypotension during procedure: defined by systolic arterial pressure less than 85mmHg or systolic arterial pressure dropped greater than 40mmHg after the use of nicorandil and lasted for 15 minutes.
Locations
Sponsors and contacts
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