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Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Shexiang Tongxin Dropping Pills + routine treatment
routine treatment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years old, no gender limit;
  • Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned;
  • Infarct-related coronary vascular anatomy is suitable for PCI treatment;
  • Agree and cooperate to participate in this research, and sign an informed consent form

Exclusion Criteria:

  • Past history of myocardial infarction history;
  • The arteries related to infarction have received PCI in the past;
  • Past CABG history;
  • Killip grade of cardiac function ≥ grade III or cardiogenic shock;
  • Systolic blood pressure ≤90mmHg;
  • Bradycardia, heart rate <60 beats/min, or atrioventricular block of degree II or more;
  • Allergic to Shexiang Tongxin Dropping Pills
  • Past history of asthma or severe COPD;
  • Severe liver and kidney dysfunction;
  • Participate in other clinical trials within 3 months;
  • Pregnancy or breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    Shexiang Tongxin dripping pills + routine treatment

    routine treatment

    Outcomes

    Primary Outcome Measures

    IMR
    microcirculation resistance index

    Secondary Outcome Measures

    Myocardial injury markers
    cardiac enzymes and troponin T

    Full Information

    First Posted
    June 27, 2021
    Last Updated
    July 4, 2021
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04952259
    Brief Title
    Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI
    Official Title
    Evaluation of the Effect of Shexiang Tongxin Dripping Pills on Coronary Microcirculation in Patients With Acute Anterior Myocardial Infarction by Microcirculation Resistance Index
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    July 31, 2022 (Anticipated)
    Study Completion Date
    July 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction.
    Detailed Description
    Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute myocardial infarction (AMI), and ischemia-reperfusion injury (I/R) can damage the vascular endothelium through complex mechanisms, leading to microcirculation dysfunction and aggravation myocardial damage and affect the prognosis. Cell and animal experiments have proved that Shexiang Tongxin Dropping Pill has anti-inflammatory, anti-oxidant, reducing I/R damage, reducing infarct size, improving peripheral muscle microcirculation, and improving coronary slow blood flow, but it lacks directive evidences of improved coronary microcirculation in AMI patients. The microcirculation resistance index (IMR) is a parameter to evaluate the microcirculation state obtained by the pressure/temperature guidewire during PCI, which can accurately and quantitatively reflect the patient's coronary microcirculation state. In this study, patients with acute anterior wall elevation ST-segment myocardial infarction (STEMI) who were prospectively selected for direct PCI treatment were randomly divided into treatment group and control group. The treatment group was given Shexiang Tongxin Dropping Pills before PCI and received direct PCI treatment, the control group only received direct PCI treatment. The IMR of the two groups was detected immediately after PCI, and the differences in IMR values, myocardial injury markers and cardiac function parameters between the two groups were analyzed. It is hoped to prove that Shexiang Tongxin dripping pills have coronary microcirculation protection in acute anterior wall elevation ST-segment myocardial infarction with undergoing direct PCI treatment, and the effect is rapid, so as to provide a basis for optimizing AMI treatment strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Shexiang Tongxin dripping pills + routine treatment
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    routine treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Shexiang Tongxin Dropping Pills + routine treatment
    Other Intervention Name(s)
    drugs and surgery
    Intervention Description
    oral+percutaneous coronary intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    routine treatment
    Other Intervention Name(s)
    surgery
    Intervention Description
    percutaneous coronary intervention
    Primary Outcome Measure Information:
    Title
    IMR
    Description
    microcirculation resistance index
    Time Frame
    detected immediately after percutaneous coronary intervention
    Secondary Outcome Measure Information:
    Title
    Myocardial injury markers
    Description
    cardiac enzymes and troponin T
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old, no gender limit; Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned; Infarct-related coronary vascular anatomy is suitable for PCI treatment; Agree and cooperate to participate in this research, and sign an informed consent form Exclusion Criteria: Past history of myocardial infarction history; The arteries related to infarction have received PCI in the past; Past CABG history; Killip grade of cardiac function ≥ grade III or cardiogenic shock; Systolic blood pressure ≤90mmHg; Bradycardia, heart rate <60 beats/min, or atrioventricular block of degree II or more; Allergic to Shexiang Tongxin Dropping Pills Past history of asthma or severe COPD; Severe liver and kidney dysfunction; Participate in other clinical trials within 3 months; Pregnancy or breastfeeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liyun He
    Phone
    +8613901132937
    Email
    hly26@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liyun He
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI

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