Coronary Heart Disease
Conditions
Keywords
nicorandil, primary percutaneous coronary intervention, acute ST segment elevation myocardial infarction, cardiac sympathetic nerve
Brief summary
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
Detailed description
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.
Interventions
DRUGnicorandil
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
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
Sponsors
Xuzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the delayed heart/mediastinum count (H/M) ratio | 10 days after primary PCI | The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total defect score (TDS) | 10 days after primary PCI | The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images |
| Rate of slow re-flow/no-reflow phenomenon | 5 minutes after primary PCI | TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery |
| Rate fo complete ST-segment resolution | 2 hours after primary PCI | ST-segment resolution \>50 percent in ECG |
| Rate of unplanned hospitalization for heart failure | 6 months after primary PCI | Rate of unplanned hospitalization for heart failure |
| The washout rate (WR) | 10 days after primary PCI | The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images |
Contacts
Primary Contactchunguang Feng, PhD
Outcome results
None listed