Clinical trial NCT04033861: Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST Segment Elevated Myocardial Infarction
Keywords: ST Segment Elevated Myocardial Infarction
rhBNP
cardiac magnetic resonance
Microvascular disease
ventricular remodeling
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: Shanghai Minhang Central Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Suqian First Hospital
First posted: 2019-07-26
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compound endpoints of epicardium and endocardium perfusion
timeFrame: 90min after infarct related artery revascularization
Secondary outcomes:
measure: ST-segment Resolution
timeFrame: 90 mins after PCI
measure: Wall motion score index (WMSI) and LVEF by echocardiography
timeFrame: Day 1, 3, 7, 30 and 12 month after PCI
measure: TIMI Flow Grade (TFG)
timeFrame: One mins after PCI
measure: TIMI Frame Count (CTFC)
timeFrame: One mins after PCI
measure: TIMI Myocardial Perfusion Grade (TMPG)
timeFrame: One mins after PCI
measure: TIMI Myocardial Perfusion Frame Count (TMPFC)
timeFrame: One mins after PCI
measure: CMR imaging
timeFrame: Day 1, 3, 7, 30 and 12 month after PCI
Other outcomes:
measure: hemodynamic adverse related to rhBNP
timeFrame: 72 hour since rhBNP administration
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong Univers
name: Jun Pu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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