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

Coronary Syndrome Clinical Trial

— STEMI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881552
• Other study ID #: RECHMPL21_0232
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: May 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Syndrome
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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