Early rhBNP on Myocardial Work in Patients With STEMI

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: ST-Segment Elevated Myocardial Infarction

Treatments: Drug: rhBNP; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04157868

EARLY MYO-myocardial work

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

rhBNP

Experimental group

Description:

rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.

Treatment:

Drug: rhBNP

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Control