Back to resultsEarly rhBNP on Myocardial Work in Patients With STEMI
Primary Purpose
ST-Segment Elevated Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rhBNP
Control
Sponsored by
About this trial
This is an interventional treatment trial for ST-Segment Elevated Myocardial Infarction focused on measuring ST-Segment Elevated Myocardial Infarction, rhBNP, non-invasive myocardial work
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rhBNP
Control
Arm 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.
Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.
Outcomes
Primary Outcome Measures
Global myocardial work efficiency by echocardiography
Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram.
Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.
Secondary Outcome Measures
Global myocardial work index by echocardiography
Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening.
Global myocardial constructive work by echocardiography
Global myocardial constructive work (mm Hg %), an estimate of the work performed by the LV segments consisting of shortening during systole plus lengthening in isovolumic relaxation.
Global myocardial waste work by echocardiography
Global myocardial waste work (mm Hg %), an estimate of negative work of the LV segments consisting of myocardial lengthening during systole plus any shortening during isovolumic relaxation.
Clinical Outcomes
Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke;
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04157868
Brief Title
Early rhBNP on Myocardial Work in Patients With STEMI
Official Title
The Impact of Early rhBNP on Myocardial Work in Patients With Anterior ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2019 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-Segment Elevated Myocardial Infarction
Keywords
ST-Segment Elevated Myocardial Infarction, rhBNP, non-invasive myocardial work
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhBNP
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.
Intervention Type
Drug
Intervention Name(s)
rhBNP
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.
Primary Outcome Measure Information:
Title
Global myocardial work efficiency by echocardiography
Description
Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram.
Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.
Time Frame
30 days after PCI
Secondary Outcome Measure Information:
Title
Global myocardial work index by echocardiography
Description
Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening.
Time Frame
Day 1, 7, 30 after PCI
Title
Global myocardial constructive work by echocardiography
Description
Global myocardial constructive work (mm Hg %), an estimate of the work performed by the LV segments consisting of shortening during systole plus lengthening in isovolumic relaxation.
Time Frame
Day 1, 7, 30 after PCI
Title
Global myocardial waste work by echocardiography
Description
Global myocardial waste work (mm Hg %), an estimate of negative work of the LV segments consisting of myocardial lengthening during systole plus any shortening during isovolumic relaxation.
Time Frame
Day 1, 7, 30 after PCI
Title
Clinical Outcomes
Description
Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke;
Time Frame
30 days after PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Ding, MD,Ph.D.
Phone
86-21-68383477
Email
dingsong1105@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Ding, MD,Ph.D.
Organizational Affiliation
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Early rhBNP on Myocardial Work in Patients With STEMI
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