Clincosm LogoSign in Get a demo

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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04952259
Collaborator
(none)
60
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Shexiang Tongxin Dropping Pills + routine treatment
  • Procedure: routine treatment
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Shexiang Tongxin dripping pills + routine treatment

Drug: Shexiang Tongxin Dropping Pills + routine treatment
oral+percutaneous coronary intervention
Other Names:
  • drugs and surgery

    		•
    Active Comparator: Control group

    routine treatment

    Procedure: routine treatment
    percutaneous coronary intervention
    Other Names:
  • surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IMR [detected immediately after percutaneous coronary intervention]

      microcirculation resistance index

    Secondary Outcome Measures

    1. Myocardial injury markers [72 hours]

      cardiac enzymes and troponin T

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Director: Liyun He, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04952259
    Other Study ID Numbers:
    • M2019480
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Jul 7, 2021