Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-02-28

Brief Summary

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The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

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Detailed Description

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Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc.

Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.

The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nicorandil

Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

Group Type EXPERIMENTAL

nicorandil

Intervention Type DRUG

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

Placebo （normal saline）

Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention

Group Type PLACEBO_COMPARATOR

Placebo（normal saline）

Intervention Type DRUG

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

Interventions

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nicorandil

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

Intervention Type DRUG

Placebo（normal saline）

All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention

Intervention Type DRUG

Other Intervention Names

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Experiment Group Control Group

Eligibility Criteria

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Inclusion Criteria

1. acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
2. Age20-80,All genders
3. anterior myocardial infarction
4. The first myocardial infarction
5. The infarct-related artery(IRA) is totally occlusive
6. Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
7. The time from myocardial infarction onset to reach the hospital is less than 12 hs

Exclusion Criteria

1. kidney dysfunction (creatinine \>2 mg/dl),
2. History of previous liver disease,
3. Cardiogenic shock,
4. History of myocardial infarction (MI)
5. History of coronary artery bypass grafting
6. History of allergic response to drugs
7. Severe hypovolemia

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No