A Phase 4 interventional study of nicorandil and Placebo（normal saline） in Coronary Heart Disease, sponsored by Xuzhou Central Hospital. Status unknown. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Xuzhou Central Hospital · Phase 4, Interventional, and Prevention
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
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Drug: nicorandil
Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention
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 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
Also known as: Experiment Group
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
Also known as: Control Group
Comparison of the delayed heart/mediastinum count (H/M) ratio
The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images
Time frame: 10 days after primary PCI
The total defect score (TDS)
The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images
Time frame: 10 days after primary PCI
Rate of slow re-flow/no-reflow phenomenon
TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery
Time frame: 5 minutes after primary PCI
Rate fo complete ST-segment resolution
ST-segment resolution \>50 percent in ECG
Time frame: 2 hours after primary PCI
Rate of unplanned hospitalization for heart failure
Rate of unplanned hospitalization for heart failure
Time frame: 6 months after primary PCI
The washout rate (WR)
The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images
Time frame: 10 days after primary PCI
The total defect score (TDS)
The total defect score was determined from 99mTc-pyrophosphate scintigraphy
Time frame: 7 days after primary PCI
No study locations are listed for this record.
Plan to share: No
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Xuzhou Central Hospital