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Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04881552
Collaborator
Centre Hospitalier Universitaire de Nīmes (Other)
302
Enrollment
1
Location
11
Actual Duration (Months)
27.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The rapid and complete restoration of coronary flow is a key issue in the management of STEMI. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy associated with antithrombotic drugs.

In daily practice, it is not rare that some patients may achieve reopening of the culprit artery without undergoing any mechanical reperfusion therapy, which is called " spontaneous reperfusion ". The latter is associated with improved outcomes in several studies but none of these studies were done in the modern antithrombotic strategy area including new P2Y12 inhibitors. The aim of this study is to report the incidence, characteristics and outcomes of consecutive patients with STEMI admitted for coronary angiography with angiographic clinical evidence of spontaneous reperfusion in the modern medical antithrombotic strategy associated with primary PCI.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    302 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Nov 1, 2020
    Actual Study Completion Date :
    May 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    non-spontaneous reperfusion group at initial emergency coronary angiography (TIMI flow grade 0-II)
    Arm 2

    spontaneous reperfusion group at initial emergency coronary angiography (TIMI flow grade III)

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of initial spontaneous coronary TIMI flow grade III [At admission]

      Incidence of initial spontaneous coronary TIMI flow grade III on coronary angiography before PCI in patients admitted for STEMI during a 6 month study period

    Secondary Outcome Measures

    1. Biological parameters [at 6 months]

      biological parameters in the 2 groups of patients with or without spontaneous reperfusion including troponin pic at admission and during hospitalization stay Type and delay of administration of the antithrombotic preloading therapy in the 2 groups Clinical follow -up regarding major cardiovascular events at 6 months follow-up in the 2 groups

    2. Biological parameters [at 12 months]

      biological parameters in the 2 groups of patients with or without spontaneous reperfusion including troponin pic at admission and during hospitalization stay Type and delay of administration of the antithrombotic preloading therapy in the 2 groups Clinical follow -up regarding major cardiovascular events at 12 months follow-up in the 2 groups

    3. Clinical events [at 6 months]

      Clinical events in the 2 groups of patients with or without spontaneous reperfusion including troponin pic at admission and during hospitalization stay Type and delay of administration of the antithrombotic preloading therapy in the 2 groups Clinical follow -up regarding major cardiovascular events at 6 months follow-up in the 2 groups

    4. Clinical events [at 12 months]

      Clinical events in the 2 groups of patients with or without spontaneous reperfusion including troponin pic at admission and during hospitalization stay Type and delay of administration of the antithrombotic preloading therapy in the 2 groups Clinical follow -up regarding major cardiovascular events at 12 months follow-up in the 2 groups

    Eligibility Criteria

    Criteria

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

    • Older than 18 years old.

    • patients with ongoing (within 12 hours after onset of symptoms) STEMI admitted for coronary angiography and receiving preloading dose of aspirin, heparin and P2Y12 inhibitor

    Exclusion criteria:

    • Patients with thrombolysis treatment before angiography

    • Patients with cardiac arrest without ST-segment elevation on ECG after resuscitation

    • Patients with myocardial infarction outside of acute phase (pain lasting more 12 hours)

    • Patients with mental disease

    • Patients not living in France

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier
    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Study Director: Florence Leclercq, PU PH, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04881552
    Other Study ID Numbers:
    • RECHMPL21_0232
    First Posted:
    May 11, 2021
    Last Update Posted:
    May 11, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of May 11, 2021