Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChina National Center for Cardiovascular Diseases

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • nicorandil

    Drug

    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)

    Drug

    In 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

170 Participants
are divided into 2 treatment groups
Group A: Nicorandil groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The time immediate after primary PCI

Secondary outcomes

1

Prevalence of slow flow or no-flow during procedure

Time frame
During primary PCI procedure
2

ST-segment resolution two hours after primary PCI

Analyze the elevated leads of EKG two hours after primary PCI

Time frame
Two hours after primary PCI
3

In-hospital peak troponin level

Time frame
From the enrollment to 7 days after primary PCI
4

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.

Time frame
During primary PCI procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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