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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Syndrome

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of initial spontaneous coronary TIMI flow grade III	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	At admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological parameters	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	at 6 months
Biological parameters	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	at 12 months
Clinical events	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	at 6 months
Clinical events	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	at 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Florence Leclercq, PU PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: RECHMPL21_0232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No