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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicorandil | Experimental | Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention |
|
| Placebo （normal saline） | Placebo Comparator | Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicorandil | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days after primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| The total defect score (TDS) | The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chunguang Feng, PhD | Contact | +8618936376559 | fcg999@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Institute of Cardiovascular Disease Xuzhou Central Hospital | Southeast University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28886621 | Result | Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available. | |
| 12607706 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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|
|
| Placebo（normal saline） | 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 |
|
|
| 5 minutes after primary PCI |
| Rate fo complete ST-segment resolution | ST-segment resolution >50 percent in ECG | 2 hours after primary PCI |
| Rate of unplanned hospitalization for heart failure | Rate of unplanned hospitalization for heart failure | 6 months after primary PCI |
| The washout rate (WR) | The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images | 10 days after primary PCI |
| The total defect score (TDS) | The total defect score was determined from 99mTc-pyrophosphate scintigraphy | 7 days after primary PCI |
| Result |
| Piper HM, Meuter K, Schafer C. Cellular mechanisms of ischemia-reperfusion injury. Ann Thorac Surg. 2003 Feb;75(2):S644-8. doi: 10.1016/s0003-4975(02)04686-6. |
| 31147987 | Result | Ji Z, Zhang R, Lu W, Ma G, Qu Y. The effect of nicorandil in patients with acute myocardial infarction undergoing percutaneous coronary intervention: a systematic review and meta-analysis. Ir J Med Sci. 2020 Feb;189(1):119-131. doi: 10.1007/s11845-019-02034-3. Epub 2019 May 30. |
| 31118574 | Result | Xu L, Wang L, Li K, Zhang Z, Sun H, Yang X. Nicorandil prior to primary percutaneous coronary intervention improves clinical outcomes in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 Apr 29;13:1389-1400. doi: 10.2147/DDDT.S195918. eCollection 2019. |
| 28966311 | Result | Fukui Y, Nozawa T, Ihori H, Sobajima M, Nakadate T, Matsuki A, Nonomura M, Fujii N, Inoue H, Kinugawa K. Nicorandil Attenuates Ischemia-Reperfusion Injury Via Inhibition of Norepinephrine Release From Cardiac Sympathetic Nerve Terminals. Int Heart J. 2017 Oct 21;58(5):787-793. doi: 10.1536/ihj.16-391. Epub 2017 Sep 30. |
| 15791442 | Result | Kasama S, Toyama T, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Effects of nicorandil on cardiac sympathetic nerve activity after reperfusion therapy in patients with first anterior acute myocardial infarction. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):322-8. doi: 10.1007/s00259-004-1672-0. Epub 2004 Oct 2. |
| 29495982 | Result | Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048. |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000147 |
| Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |