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Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

Primary Purpose

ST Segment Elevated Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rhBNP
Control
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Segment Elevated Myocardial Infarction focused on measuring ST Segment Elevated Myocardial Infarction, rhBNP, cardiac magnetic resonance, Microvascular disease, ventricular remodeling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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

Sites / Locations

  • Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong UniversityRecruiting

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

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.

Secondary Outcome Measures

ST-segment Resolution
Resolution of the initial sum of ST-segment elevation ≥ 70%
Wall motion score index (WMSI) and LVEF by echocardiography
Echocardiographic index includes WMSI and LVEF
TIMI Flow Grade (TFG)
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
TIMI Frame Count (CTFC)
CTFC is a continuous measurement assessing flow in the epicardial arteries.
TIMI Myocardial Perfusion Grade (TMPG)
TMPG is an angiographic measure of myocardial perfusion
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
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.

Full Information

First Posted
January 24, 2019
Last Updated
May 30, 2023
Sponsor
RenJi Hospital
Collaborators
Shanghai 6th People's Hospital, Shanghai Minhang Central Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Suqian First People's Hospital in Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT04033861
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Shanghai 6th People's Hospital, Shanghai Minhang Central Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Suqian First People's Hospital in Jiangsu Province

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 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.

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, cardiac magnetic resonance, Microvascular disease, ventricular remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
352 (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
Compound endpoints of epicardium and endocardium perfusion
Description
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
Secondary Outcome Measure Information:
Title
ST-segment Resolution
Description
Resolution of the initial sum of ST-segment elevation ≥ 70%
Time Frame
90 mins after PCI
Title
Wall motion score index (WMSI) and LVEF by echocardiography
Description
Echocardiographic index includes WMSI and LVEF
Time Frame
Day 1, 3, 7, 30 and 12 month after PCI
Title
TIMI Flow Grade (TFG)
Description
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
Time Frame
One mins after PCI
Title
TIMI Frame Count (CTFC)
Description
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Time Frame
One mins after PCI
Title
TIMI Myocardial Perfusion Grade (TMPG)
Description
TMPG is an angiographic measure of myocardial perfusion
Time Frame
One mins after PCI
Title
TIMI Myocardial Perfusion Frame Count (TMPFC)
Description
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
Title
CMR imaging
Description
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
Other Pre-specified Outcome Measures:
Title
hemodynamic adverse related to rhBNP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Pu, MD,PhD
Phone
86-21-68383477
Email
pujun310@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Pu, MD,PhD
Organizational Affiliation
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong Univers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Pu, MD,PHD
Phone
86-21-68383477
Email
pujun310@hotmail.com

12. IPD Sharing Statement

Citations:
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Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

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