Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04033861

Collaborator

(none)

352

Enrollment

Location

Arms

Anticipated Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ST Segment Elevated Myocardial Infarction	Drug: rhBNP Drug: Control	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

352 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 30, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Placebo Comparator: Control saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.	Drug: Control saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.

Arm

Intervention/Treatment

Experimental: 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.

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.

Placebo Comparator: Control

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

Drug: Control

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

Outcome Measures

Primary Outcome Measures

Compound endpoints of epicardium and endocardium perfusion [90min after infarct related artery revascularization]
Both the TIMI and TMPG score reach 3 immediately after PCI, besides ST resolution≥70% at 90min after PCI.

Secondary Outcome Measures

ST-segment Resolution [90 mins after PCI]
Resolution of the initial sum of ST-segment elevation ≥ 70%
Wall motion score index (WMSI) and LVEF by echocardiography [Day 1, 3, 7, 30 and 12 month after PCI]
Echocardiographic index includes WMSI and LVEF
TIMI Flow Grade (TFG) [One mins after PCI]
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
TIMI Frame Count (CTFC) [One mins after PCI]
CTFC is a continuous measurement assessing flow in the epicardial arteries.
TIMI Myocardial Perfusion Grade (TMPG) [One mins after PCI]
TMPG is an angiographic measure of myocardial perfusion
TIMI Myocardial Perfusion Frame Count (TMPFC) [One mins after PCI]
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
CMR imaging [Day 1, 3, 7, 30 and 12 month after PCI]
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.

Other Outcome Measures

hemodynamic adverse related to rhBNP [72 hour since rhBNP administration]
low perfusion sign, and Noninvasive systolic blood pressure is below 90mmHg with or without diastolic blood pressure below 60mmHg, Excluding other reason.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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