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Effect of rhBNP on CMD in Patients With STEMI After PPCI

Primary Purpose

STEMI

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
recombinant human B-type natriuretic peptide
Sponsored by
Henan Institute of Cardiovascular Epidemiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: STEMI PPCI within 24 hours of symptom onset Target vessel QFR-MR>250mm Hg*s/m Exclusion Criteria: claustrophobia Postoperative TIMI grade 0-1 Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental Group 1

    Control Gruop

    Arm Description

    The experimental group was given neoptin within 3h after PCI for 72 hours (first at 1.5μg /kg intravenous load, then at 0.015μg /kg/min).

    The experimental group was given an intravenous infusion of the same amount of normal saline

    Outcomes

    Primary Outcome Measures

    MVO/LV(%)
    Microvascular obstruction assessed by magnetic resonance imaging

    Secondary Outcome Measures

    LGE/LV(%)
    Cardiac magnetic resonance imaging
    IMH
    Intramuscular hemorrhageCardiac assessed by magnetic resonance imaging
    MVO/LV(%)
    Microvascular obstruction assessed by magnetic resonance imaging
    LVEDV(ml)
    Assessed by magnetic resonance imaging
    LVESV(ml)
    Assessed by magnetic resonance imaging
    Troponin (highest value)
    Troponin (highest value)
    MACCEs
    Major Adverse Cardiac and Cerebrovascular event：Death, nonfatal myocardial infarction, heart failure, revascularization, stroke

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 1, 2023
    Sponsor
    Henan Institute of Cardiovascular Epidemiology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05723315
    Brief Title
    Effect of rhBNP on CMD in Patients With STEMI After PPCI
    Official Title
    Effect of rhBNP on Coronary Microcirculation in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2023 (Anticipated)
    Primary Completion Date
    December 20, 2024 (Anticipated)
    Study Completion Date
    December 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Henan Institute of Cardiovascular Epidemiology

    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 target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI
    Detailed Description
    Direct percutaneous coronary intervention is the preferred reperfusion strategy for acute ST-segment elevation myocardial infarction. During the opening of infarct-related vessels, 5%-50% of patients showed slow flow or no reflow and other coronary microcirculation dysfunction, which aggravated myocardial injury and increased the incidence and mortality of heart failure. Studies have shown that recombinant human brain natriuretic peptide (rhBNP) can reduce reperfusion injury and reduce myocardial infarction area CMD. Prolonged ischemia leads to rapid depletion of intracellular ATP and tissue metabolic acidosis. Blood flow irrigation during reperfusion leads to decreased levels of ATP precursors, calcium overload in mitochondria, release of a large number of inflammatory factors and oxygen free radicals, which can lead to injury or death of myocardial and endothelial cells. rhBNP can enhance the activity of antioxidant enzymes, reduce the irreversible oxidative damage caused by free radicals to myocardium, reduce the myocardial infarction area during ischemia reperfusion, and may reduce the reperfusion injury and protect the viable myocardium.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    STEMI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group 1
    Arm Type
    Experimental
    Arm Description
    The experimental group was given neoptin within 3h after PCI for 72 hours (first at 1.5μg /kg intravenous load, then at 0.015μg /kg/min).
    Arm Title
    Control Gruop
    Arm Type
    No Intervention
    Arm Description
    The experimental group was given an intravenous infusion of the same amount of normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    recombinant human B-type natriuretic peptide
    Other Intervention Name(s)
    rhBNP
    Intervention Description
    The recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide
    Primary Outcome Measure Information:
    Title
    MVO/LV(%)
    Description
    Microvascular obstruction assessed by magnetic resonance imaging
    Time Frame
    3-14 days after PPCI
    Secondary Outcome Measure Information:
    Title
    LGE/LV(%)
    Description
    Cardiac magnetic resonance imaging
    Time Frame
    3-14 days and 90±7 days after PPCI
    Title
    IMH
    Description
    Intramuscular hemorrhageCardiac assessed by magnetic resonance imaging
    Time Frame
    3-14 days after PPCI
    Title
    MVO/LV(%)
    Description
    Microvascular obstruction assessed by magnetic resonance imaging
    Time Frame
    30±7 days after PPCI
    Title
    LVEDV(ml)
    Description
    Assessed by magnetic resonance imaging
    Time Frame
    3-14 days and 90±7 days after PPCI
    Title
    LVESV(ml)
    Description
    Assessed by magnetic resonance imaging
    Time Frame
    3-14 days and 90±7 days after PPCI
    Title
    Troponin (highest value)
    Description
    Troponin (highest value)
    Time Frame
    3-14 days after PPCI
    Title
    MACCEs
    Description
    Major Adverse Cardiac and Cerebrovascular event：Death, nonfatal myocardial infarction, heart failure, revascularization, stroke
    Time Frame
    7days，30days，3months，6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: STEMI PPCI within 24 hours of symptom onset Target vessel QFR-MR>250mm Hg*s/m Exclusion Criteria: claustrophobia Postoperative TIMI grade 0-1 Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quan Guo
    Phone
    +8615670510031
    Email
    xinyiguoquan@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muwei Li, MD
    Organizational Affiliation
    Fuwai central China cardiovascular hospotial
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of rhBNP on CMD in Patients With STEMI After PPCI

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