Early rhBNP on Myocardial Work in Patients With STEMI

NCT04157868 | Unknown Phase 4 DMC

• 1 other identifier: EARLY MYO-myocardial work
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

ST-Segment Elevated Myocardial Infarction

Keywords

ST-Segment Elevated Myocardial Infarction; rhBNP; non-invasive myocardial work

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Global myocardial work index by echocardiography

  Day 1, 7, 30 after PCI

• Global myocardial constructive work by echocardiography

  Day 1, 7, 30 after PCI

• Global myocardial waste work by echocardiography

  Day 1, 7, 30 after PCI

• Clinical Outcomes

  30 days after PCI

Study Arms (2)

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.

Drug: rhBNP

Control

PLACEBO COMPARATOR

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.

Drug: Control

Interventions

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.

rhBNP

Control DRUG

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• \. No contraindication for rhBNP;
• \. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

You may not qualify if:

• Cardiogenic shock (systolic BP \<90mmHg after fluid infusion or systolic BP\<100mmHg after vasoactive drugs);
• \. History of myocardial infarct;
• Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;
• \. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;
• \. Pregnant or lactating;
• \. life expectancy≤12 months;
• \. 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;

Sponsors & Collaborators

• RenJi Hospital: lead

Related Publications (14)

• 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.

  PMID: 21712046 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.

  PMID: 19608025 BACKGROUND

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.

  PMID: 24352519 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.

  PMID: 21173361 BACKGROUND

• Postma S, Dambrink JH, Gosselink AT, Ottervanger JP, Kolkman E, Ten Berg JM, Suryapranata H, van 't Hof AW. The influence of system delay on 30-day and on long-term mortality in patients with anterior versus non-anterior ST-segment elevation myocardial infarction: a cohort study. Open Heart. 2015 Apr 10;2(1):e000201. doi: 10.1136/openhrt-2014-000201. eCollection 2015.

  PMID: 25893101 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.

  PMID: 18252972 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.

  PMID: 19356529 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.

  PMID: 21511433 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.

  PMID: 29529181 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.

  PMID: 19666722 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.

  PMID: 31043359 BACKGROUND

• Masci PG, Marinelli M, Piacenti M, Lorenzoni V, Positano V, Lombardi M, L'Abbate A, Neglia D. Myocardial structural, perfusion, and metabolic correlates of left bundle branch block mechanical derangement in patients with dilated cardiomyopathy: a tagged cardiac magnetic resonance and positron emission tomography study. Circ Cardiovasc Imaging. 2010 Jul;3(4):482-90. doi: 10.1161/CIRCIMAGING.109.934638. Epub 2010 May 12.

  PMID: 20463209 BACKGROUND

• Duchenne J, Turco A, Unlu S, Pagourelias ED, Vunckx K, Degtiarova G, Bezy S, Cvijic M, Nuyts J, Claus P, Rega F, Gheysens O, Voigt JU. Left Ventricular Remodeling Results in Homogenization of Myocardial Work Distribution. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007224. doi: 10.1161/CIRCEP.118.007224.

  PMID: 31023060 BACKGROUND

• Boe E, Russell K, Eek C, Eriksen M, Remme EW, Smiseth OA, Skulstad H. Non-invasive myocardial work index identifies acute coronary occlusion in patients with non-ST-segment elevation-acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2015 Nov;16(11):1247-55. doi: 10.1093/ehjci/jev078. Epub 2015 Apr 6.

  PMID: 25851329 BACKGROUND

Study Officials

• Song Ding, MD,Ph.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Ding, MD,Ph.D.

CONTACT

86-21-68383477; dingsong1105@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 8, 2019
• Study Start: November 30, 2019
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 8, 2019

Record last verified: 2019-11