Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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ST Segment Elevated Myocardial Infarction

Intervention / Treatment
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* Drug: rhBNP
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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: Killips grade III-IV. unstable hemodynamic; with A-V block or atrial fibrillation; Contraindication of magnetic resonance, such as history of metal, ICD or paceman implant; history of myocardial infarct; pregnancy or breeding; combined with other serious diseases: severe renal dysfunction (creatinine clearance<30ml/min;), liver failure, neutropenia, thrombocytopenia, acute pancreatitis； life expectancy≤12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBNP<br>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<br>* rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.<br>|
| Placebo Comparator: Control<br>saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization. | Drug: Control<br>* saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST-segment Resolution | Resolution of the initial sum of ST-segment elevation ≥ 70% | 90 mins after PCI | 
| 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 | 
| TIMI Flow Grade (TFG) | TIMI Flow Grade (TFG)assesses flow in the epicardial arteries | One mins after PCI | 
| TIMI Frame Count (CTFC) | CTFC is a continuous measurement assessing flow in the epicardial arteries. | One mins after PCI | 
| TIMI Myocardial Perfusion Grade (TMPG) | TMPG is an angiographic measure of myocardial perfusion | One mins after PCI | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Segment Elevated Myocardial Infarction, rhBNP, cardiac magnetic resonance, Microvascular disease, ventricular remodeling