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Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04952740
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
17.9
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: IPC+PCI
  • Procedure: No IPC
 N/A

Detailed Description

This study is a clinical randomized controlled study, applying index of microcirculatory resistance (IMR) to evaluate the myocardial protection of ischemic postconditioning (IPC) in patients receiving direct PCI treatment for acute myocardial infarction.IMR is a quantitative evaluation index of microcirculation status. IPC has been reported to reduce ischemia-reperfusion injury and has a myocardial protective effect.The research plan divides patients into IPC and non-IPC groups at random. After the infarction-related artery is successfully implanted with a stent, the pressure guide wire is used to measure IMR and CFR in the state of maximal expansion of the microcirculation induced by intravenous ATP infusion.And analyze whether there are differences in indicators between the two groups and the relationship between these indicators and the patient's myocardial level reperfusion, cardiac function and prognosis.The purpose is to evaluate the myocardial protection of IPC and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients. It is expected that the target IPC can improve the IMR value, and IMR can predict the degree of myocardial reperfusion and cardiac function and prognosis.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Application of Index of Microcirculatory Resistance to Evaluate Myocardial Protection After Ischemic Adaptation
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Jun 30, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ischemic postconditioning

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles

Procedure: IPC+PCI
Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles
Other Names:
  • Ischemic postconditioning

    		•
    Active Comparator: No Ischemic postconditioning

    Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.)

    Procedure: No IPC
    Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.
    Other Names:
  • Routine PCI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IMR [detected immediately after percutaneous coronary intervention]

      index of microcirculatory resistance measured during coronary intervention.

    Secondary Outcome Measures

    1. MACEs after PCI [6 months]

      MACEs includes cardiogenic death, non-fatal myocardial infarction, malignant arrhythmia, unplanned revascularization, unstable angina pectoris requiring hospitalization and severe heart failure requiring hospitalization

    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;

    • First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;

    • Agree and cooperate to participate in this research.

    Exclusion Criteria:

    • Old myocardial infarction;

    • Killip grade of cardiac function ≥ grade III or cardiogenic shock;

    • Systolic blood pressure ≤100mmHg;

    • Bradycardia, HR<60pbm, or AVB above II degree;

    • Past history of asthma or severe COPD;

    • Severe liver and kidney dysfunction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University third hospital Beijing Beijing China 100089

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Principal Investigator: Lijun Lijun, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04952740
    Other Study ID Numbers:
    • 2013127
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jan 1, 2014
    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 9, 2021