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NCT Number: NCT04881552

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

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.

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Key information

Conditions

Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of initial spontaneous coronary TIMI flow grade III

    Time frame: 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 outcomes

  1. Biological parameters

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Registry information

Acronym: STEMI

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 11, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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