Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

NCT04033861 | Unknown Phase 4 DMC

• 1 other identifier: rhBNP-myocardium
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ST Segment Elevated Myocardial Infarction

Keywords

ST Segment Elevated Myocardial Infarction; rhBNP; cardiac magnetic resonance; Microvascular disease; ventricular remodeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• ST-segment Resolution

  90 mins after PCI

• Wall motion score index (WMSI) and LVEF by echocardiography

  Day 1, 3, 7, 30 and 12 month after PCI

• TIMI Flow Grade (TFG)

  One mins after PCI

• TIMI Frame Count (CTFC)

  One mins after PCI

• TIMI Myocardial Perfusion Grade (TMPG)

  One mins after PCI

Other Outcomes (1)

• hemodynamic adverse related to rhBNP

  72 hour since rhBNP administration

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+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai 6th People's Hospital: collaborator
• Shanghai Minhang Central Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Suqian First Hospital: collaborator

Study Sites (1)

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

Shanghai, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 19960517 BACKGROUND

• 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.

  PMID: 19923168 BACKGROUND

• 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.

  PMID: 10637197 BACKGROUND

• 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.

  PMID: 9639373 BACKGROUND

• 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.

  PMID: 22883082 BACKGROUND

• 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.

  PMID: 23806080 BACKGROUND

• 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.

  PMID: 11153779 BACKGROUND

• 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.

  PMID: 21176835 BACKGROUND

• 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.

  PMID: 20009495 BACKGROUND

• 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.

  PMID: 21670242 BACKGROUND

• 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.

  PMID: 22094974 BACKGROUND

MeSH Terms

Conditions

Ventricular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Pu, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu, MD,PhD

CONTACT

86-21-68383477; pujun310@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: July 26, 2019
• Study Start: June 19, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2023
• Last Updated: June 1, 2023

Record last verified: 2022-12

Locations

CN (1)