A Phase 4 interventional study of rhBNP and Control in ST Segment Elevated Myocardial Infarction, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by RenJi Hospital · Phase 4, Interventional, and Treatment
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
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 352 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.
Drug: Control
rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.
saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.
Compound endpoints of epicardium and endocardium perfusion
Both the TIMI and TMPG score reach 3 immediately after PCI, besides ST resolution≥70% at 90min after PCI.
Time frame: 90min after infarct related artery revascularization
ST-segment Resolution
Resolution of the initial sum of ST-segment elevation ≥ 70%
Time frame: 90 mins after PCI
Wall motion score index (WMSI) and LVEF by echocardiography
Echocardiographic index includes WMSI and LVEF
Time frame: Day 1, 3, 7, 30 and 12 month after PCI
TIMI Flow Grade (TFG)
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
Time frame: One mins after PCI
TIMI Frame Count (CTFC)
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Time frame: One mins after PCI
TIMI Myocardial Perfusion Grade (TMPG)
TMPG is an angiographic measure of myocardial perfusion
Time frame: One mins after PCI
TIMI Myocardial Perfusion Frame Count (TMPFC)
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
Time frame: One mins after PCI
CMR imaging
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.
Time frame: Day 1, 3, 7, 30 and 12 month after PCI
hemodynamic adverse related to rhBNP
low perfusion sign, and Noninvasive systolic blood pressure is below 90mmHg with or without diastolic blood pressure below 60mmHg, Excluding other reason.
Time frame: 72 hour since rhBNP administration
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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RenJi Hospital