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

NCT04881552 | Completed

• 1 other identifier: RECHMPL21_0232
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biological parameters

  at 6 months

• Biological parameters

  at 12 months

• Clinical events

  at 6 months

• Clinical events

  at 12 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Angina, Unstable

Condition Hierarchy (Ancestors)

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

Study Officials

• Florence Leclercq, PU PH

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: June 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

FR (1)