Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

ST Segment Elevated Myocardial Infarction Clinical Trial

Official title:

Prospective Observational Clinical Study：The Impact of Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033861
• Other study ID #: rhBNP-myocardium
• Status: Recruiting
• Phase: Phase 4
• Start date: June 19, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2022
• Source: RenJi Hospital
• Contact: Jun Pu, MD,PhD
• Phone: 86-21-68383477
• Email: pujun310[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study intends to evaluate the efficacy of early rhBNP on myocardial remodeling and reperfusion in patients with ST-segment elevation myocardial infarction after percutaneous coronary intervention

Description:

As prospectively observational study，it brings anterior acute myocardial infarct patients from 2018 JAN. to 2019 JAN, whose predefined time between symptom onset and percutaneous is not more than 12 hours. The door-to-balloon time, present to balloon time and first medical contact-to-balloon time will be documented. ECG in FMC and 90min after PCI also will be record. Patients assigned to the rhBNP group will receive intravenous rhBNP before PCI，and the variety of heart rate and blood pressure will be record. Routinely evaluation of corrected TIMI frame counting（CTFC）, TIMI myocardial perfusion frame counting and TIMI myocardial perfusion grade(TMPG).Blood tests including BNP, CK-MB and CRP are measured at admission and6, 12, 24, 48 hours after PCI. Both Cardiovascular magnetic imaging and echocardiography will be applied in Day 30 and 12 months. The composite endpoint is incidence of all-cause mortality, reinfarct, stroke and target vessel revascularization at hospitalization and follow-up. Principally patients are prevented from any drug affecting microcirculation (GPIIb/IIa receptor agonist, vascular dilation drug, etc.), otherwise it is necessary, which should be documented.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Patients are eligible for enrollment if they are suspected as 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, and no contraindication for rhBNP. The coronary angiography (CAG) proves left anterior descending (LAD) as culprit vessel, which was totally or nearly occlusion with TIMI 0-1 grade and resulted in TIMI 3 grade after PCI.

Exclusive criteria:

1. Killips grade III-IV.

2. unstable hemodynamic; with A-V block or atrial fibrillation;

3. Contraindication of magnetic resonance, such as history of metal, ICD or paceman implant;

4. history of myocardial infarct;

5. pregnancy or breeding;

6. combined with other serious diseases: severe renal dysfunction (creatinine clearance<30ml/min;), liver failure, neutropenia, thrombocytopenia, acute pancreatitis;

7. life expectancy=12 months

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Segment Elevated Myocardial Infarction

Intervention

Drug:
• rhBNP
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
saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.

Locations

Country	Name	City	State
China	Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai 6th People's Hospital, Shanghai Minhang Central Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Suqian First People's Hospital in Jiangsu Province

Country where clinical trial is conducted

China, 

References & Publications (11)

Chinese Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline of non-ST segment elevation acute coronary syndrome]. Zhonghua Xin Xue Guan Bing Za Zhi. 2012 May;40(5):353-67. No abstract available. Chinese. — View Citation

Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298. — View Citation

Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125. — View Citation

Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18. — View Citation

Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58. — View Citation

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. — View Citation

Pu J, Ding S, Shan P, Qiao Z, Song W, Du Y, Shen J, Jin S, He B. Comparison of epicardial and myocardial perfusions after primary coronary angioplasty for ST-elevation myocardial infarction in patients under and over 75 years of age. Aging Clin Exp Res. 2010 Aug;22(4):295-302. doi: 10.1007/BF03337726. Epub 2009 Dec 1. — View Citation

Pu J, Shan P, Ding S, Qiao Z, Jiang L, Song W, Du Y, Shen J, Shen L, Jin S, He B. Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction. Atherosclerosis. 2011 Mar;215(1):203-8. doi: 10.1016/j.atherosclerosis.2010.11.019. Epub 2010 Nov 26. — View Citation

Roe MT, Ohman EM, Maas AC, Christenson RH, Mahaffey KW, Granger CB, Harrington RA, Califf RM, Krucoff MW. Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion. J Am Coll Cardiol. 2001 Jan;37(1):9-18. doi: 10.1016/s0735-1097(00)01101-3. — View Citation

Shen LH, Wan F, Shen L, Ding S, Gong XR, Qiao ZQ, Du YP, Song W, Shen JY, Jin SX, Pu J, Yao TB, Jiang LS, Li WZ, Zhou GW, Liu SW, Han YL, He B. Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study. J Thromb Thrombolysis. 2012 Jan;33(1):101-8. doi: 10.1007/s11239-011-0657-7. — View Citation

van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hemodynamic adverse related to rhBNP	low perfusion sign, and Noninvasive systolic blood pressure is below 90mmHg with or without diastolic blood pressure below 60mmHg, Excluding other reason.	72 hour since rhBNP administration
Primary	Compound endpoints of epicardium and endocardium perfusion	Both the TIMI and TMPG score reach 3 immediately after PCI, besides ST resolution=70% at 90min after PCI.	90min after infarct related artery revascularization
Secondary	ST-segment Resolution	Resolution of the initial sum of ST-segment elevation = 70%	90 mins after PCI
Secondary	Wall motion score index (WMSI) and LVEF by echocardiography	Echocardiographic index includes WMSI and LVEF	Day 1, 3, 7, 30 and 12 month after PCI
Secondary	TIMI Flow Grade (TFG)	TIMI Flow Grade (TFG)assesses flow in the epicardial arteries	One mins after PCI
Secondary	TIMI Frame Count (CTFC)	CTFC is a continuous measurement assessing flow in the epicardial arteries.	One mins after PCI
Secondary	TIMI Myocardial Perfusion Grade (TMPG)	TMPG is an angiographic measure of myocardial perfusion	One mins after PCI
Secondary	TIMI Myocardial Perfusion Frame Count (TMPFC)	TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec	One mins after PCI
Secondary	CMR imaging	CMR imaging will be collected using a 3.0-Tesla-scanner (Achieva, Philips Healthcare, The Netherlands) under electrocardiogram-triggered gating in School Shanghai Jiaotong University school of medicine RenJi hospital.	Day 1, 3, 7, 30 and 12 month after PCI