Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI
- Conditions
- ST Segment Elevated Myocardial Infarction
- Interventions
- Drug: Control
- Registration Number
- NCT04033861
- Lead Sponsor
- RenJi Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 352
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Control Control saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, China