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| Name | Class |
|---|---|
| First People's Hospital of Yulin | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Wuhan Asia Heart Hospital | OTHER |
| Hainan General Hospital |
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We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI
The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group); |
|
| Placebo arm | Placebo Comparator | Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil | Drug | After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size as measured by cardiac MRI | The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians. | 7 days after primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size as measured by cardiac MRI | The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images. | 6 months after PCI |
| Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHINA | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16116055 | Result | Ishii H, Ichimiya S, Kanashiro M, Amano T, Imai K, Murohara T, Matsubara T. Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction. Circulation. 2005 Aug 30;112(9):1284-8. doi: 10.1161/CIRCULATIONAHA.104.530329. Epub 2005 Aug 22. | |
| 10080465 | Result |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D020108 | Nicorandil |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
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| OTHER |
| Zunyi Medical College | OTHER |
| Guizhou Provincial People's Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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| Placebo | Other | After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h |
|
the starting point is the number of frames in which the contrast agent completely or nearly completely filled the beginning of the coronary artery and touched both sides of the coronary vessel wall, and the end point is the number of frames in which the contrast agent entered the distal branch vessel and developed a specific anatomical marker
| 5 minutes after stent implantation during PCI |
| Incidence of slow flow/no-reflow | When scanning at a rate of 15 frames per second, cTFC > 27 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI | 5 minutes after stent implantation during PCI |
| ST-segment fall rate of electrocardiogram (ECG) | Complete ST-segment resolution at 2 h after PCI | 2 hours after the procedure |
| Serum creatinine kinase (CK-MB) level | Change of serum creatinine kinase | Baseline, 6, 12, 18, 24 hours after the PCI |
| Edema size (LV area %) measured by cardiac MRI | Edema size | 7 days after the procedure |
| Microvascular obstructionmeasured by cardiac MRI | Microvascular obstructionmeasured | 7 days after the procedure |
| LV Ejection fraction (%) as measured by cardiac MRI | LV Ejection fraction in early phase | 7 days after the procedure |
| LV Ejection fraction (%) as measured by cardiac MRI | LV Ejection fraction in late phase | 6 months after the procedure |
| MACE | all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI | up to 12 months |
| CIN | contrast induced nephropathy | 48-72 hours after primary PCI |
| Ito H, Taniyama Y, Iwakura K, Nishikawa N, Masuyama T, Kuzuya T, Hori M, Higashino Y, Fujii K, Minamino T. Intravenous nicorandil can preserve microvascular integrity and myocardial viability in patients with reperfused anterior wall myocardial infarction. J Am Coll Cardiol. 1999 Mar;33(3):654-60. doi: 10.1016/s0735-1097(98)00604-4. |
| 17964349 | Result | Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1. |
| 28279370 | Result | Bulluck H, Hammond-Haley M, Weinmann S, Martinez-Macias R, Hausenloy DJ. Myocardial Infarct Size by CMR in Clinical Cardioprotection Studies: Insights From Randomized Controlled Trials. JACC Cardiovasc Imaging. 2017 Mar;10(3):230-240. doi: 10.1016/j.jcmg.2017.01.008. |
| 17478142 | Result | Ishii H, Ichimiya S, Kanashiro M, Amano T, Ogawa Y, Mitsuhashi H, Sakai S, Uetani T, Murakami R, Naruse K, Murohara T, Matsubara T. Effect of intravenous nicorandil and preexisting angina pectoris on short- and long-term outcomes in patients with a first ST-segment elevation acute myocardial infarction. Am J Cardiol. 2007 May 1;99(9):1203-7. doi: 10.1016/j.amjcard.2006.12.034. Epub 2007 Mar 16. |
| 11965271 | Result | IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X. |
| 11693742 | Result | Okamura A, Rakugi H, Ohishi M, Yanagitani Y, Shimizu M, Nishii T, Taniyama Y, Asai T, Takiuchi S, Moriguchi K, Ohkuro M, Komai N, Yamada K, Inamoto N, Otsuka A, Higaki J, Ogihara T. Additive effects of nicorandil on coronary blood flow during continuous administration of nitroglycerin. J Am Coll Cardiol. 2001 Mar 1;37(3):719-25. doi: 10.1016/s0735-1097(00)01171-2. |
| 26012474 | Result | Kostic J, Djordjevic-Dikic A, Dobric M, Milasinovic D, Nedeljkovic M, Stojkovic S, Stepanovic J, Tesic M, Trifunovic Z, Zamaklar-Tifunovic D, Radosavljevic-Radovanovic M, Ostojic M, Beleslin B. The effects of nicorandil on microvascular function in patients with ST segment elevation myocardial infarction undergoing primary PCI. Cardiovasc Ultrasound. 2015 May 27;13:26. doi: 10.1186/s12947-015-0020-9. |
| 36073634 | Derived | Qian G, Zhang Y, Dong W, Jiang ZC, Li T, Cheng LQ, Zou YT, Jiang XS, Zhou H, A X, Li P, Chen ML, Su X, Tian JW, Shi B, Li ZZ, Wu YQ, Li YJ, Chen YD. Effects of Nicorandil Administration on Infarct Size in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The CHANGE Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e026232. doi: 10.1161/JAHA.122.026232. Epub 2022 Sep 8. |
| 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 |