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The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBNP | Experimental | rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour. |
|
| Control | Placebo Comparator | Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBNP | Drug | rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global myocardial work efficiency by echocardiography | Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram. Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage. | 30 days after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Global myocardial work index by echocardiography | Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening. | Day 1, 7, 30 after PCI |
| Global myocardial constructive work by echocardiography |
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Inclusion Criteria:
1. Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
2. No contraindication for rhBNP;
3. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.
Exclusion Criteria:
1.Cardiogenic shock (systolic BP <90mmHg after fluid infusion or systolic BP<100mmHg after vasoactive drugs);
2. History of myocardial infarct;
3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;
4. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;
5. Pregnant or lactating;
6. life expectancy≤12 months;
7. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Ding, MD,Ph.D. | Contact | 86-21-68383477 | dingsong1105@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Song Ding, MD,Ph.D. | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21712046 | Background | Schwartz BG, Kloner RA. Coronary no reflow. J Mol Cell Cardiol. 2012 Apr;52(4):873-82. doi: 10.1016/j.yjmcc.2011.06.009. Epub 2011 Jun 21. | |
| 19608025 | Background | Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054. |
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| Control | Drug | Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour. |
|
Global myocardial constructive work (mm Hg %), an estimate of the work performed by the LV segments consisting of shortening during systole plus lengthening in isovolumic relaxation. |
| Day 1, 7, 30 after PCI |
| Global myocardial waste work by echocardiography | Global myocardial waste work (mm Hg %), an estimate of negative work of the LV segments consisting of myocardial lengthening during systole plus any shortening during isovolumic relaxation. | Day 1, 7, 30 after PCI |
| Clinical Outcomes | Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke; | 30 days after PCI |
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| 21173361 | Background | Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available. |
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| 18252972 | Background | Wu GF, Wykrzykowska JJ, Rana JS, Pinto DS, Gibson CM, Li J, Sellke FW, Laham RJ. Effects of B-type natriuretic peptide (nesiritide) on coronary epicardial arteries, systemic vasculature and microvessels. J Invasive Cardiol. 2008 Feb;20(2):76-80. |
| 19356529 | Background | Sjoli B, Orn S, Grenne B, Ihlen H, Edvardsen T, Brunvand H. Diagnostic capability and reproducibility of strain by Doppler and by speckle tracking in patients with acute myocardial infarction. JACC Cardiovasc Imaging. 2009 Jan;2(1):24-33. doi: 10.1016/j.jcmg.2008.10.007. |
| 21511433 | Background | Shimoni S, Gendelman G, Ayzenberg O, Smirin N, Lysyansky P, Edri O, Deutsch L, Caspi A, Friedman Z. Differential effects of coronary artery stenosis on myocardial function: the value of myocardial strain analysis for the detection of coronary artery disease. J Am Soc Echocardiogr. 2011 Jul;24(7):748-57. doi: 10.1016/j.echo.2011.03.007. Epub 2011 Apr 20. |
| 29529181 | Background | Hubert A, Le Rolle V, Leclercq C, Galli E, Samset E, Casset C, Mabo P, Hernandez A, Donal E. Estimation of myocardial work from pressure-strain loops analysis: an experimental evaluation. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1372-1379. doi: 10.1093/ehjci/jey024. |
| 19666722 | Background | Donal E, Bergerot C, Thibault H, Ernande L, Loufoua J, Augeul L, Ovize M, Derumeaux G. Influence of afterload on left ventricular radial and longitudinal systolic functions: a two-dimensional strain imaging study. Eur J Echocardiogr. 2009 Dec;10(8):914-21. doi: 10.1093/ejechocard/jep095. Epub 2009 Aug 7. |
| 31043359 | Background | Edwards NFA, Scalia GM, Shiino K, Sabapathy S, Anderson B, Chamberlain R, Khandheria BK, Chan J. Global Myocardial Work Is Superior to Global Longitudinal Strain to Predict Significant Coronary Artery Disease in Patients With Normal Left Ventricular Function and Wall Motion. J Am Soc Echocardiogr. 2019 Aug;32(8):947-957. doi: 10.1016/j.echo.2019.02.014. Epub 2019 Apr 28. |
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