Early rhBNP on Myocardial Work in Patients With STEMI

Phase 4

• Conditions: ST-Segment Elevated Myocardial Infarction
• Interventions: Drug: Control; Drug: rhBNP

• Registration Number: NCT04157868
• Lead Sponsor: RenJi Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Study Start: 2019-11-30
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Global myocardial work efficiency by echocardiography	30 days after PCI	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes	30 days after PCI	Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke;
Global myocardial constructive work by echocardiography	Day 1, 7, 30 after PCI	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.
Global myocardial waste work by echocardiography	Day 1, 7, 30 after PCI	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.
Global myocardial work index by echocardiography	Day 1, 7, 30 after PCI	Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening.