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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04881552
Other study ID # RECHMPL21_0232
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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