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Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction

NCT02788344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6920

Last updated 2022-11-17

No results posted yet for this study

Summary

This is a multicenter multidisciplinary study designed to investigate patient, provider, and system-related factors that are associated with the quality and safety of initial management for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12 hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for suspected STEMI independently relates to provider practice patterns and system barriers. It is further postulated that non-compliance with target delays in implementing percutaneous coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion therapy within target delays is associated with increased rates of false-positive cardiac catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events.

The project will be conducted in three emergency medical services and 23 public and private (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over the index hospital stay period will be retrospectively collected for all the patients included in an ongoing prospective regional hospital-based clinical registry of suspected STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is anticipated.

In this observational retrospective study, no specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. No enrollment or follow-up visits are planned.

The primary effectiveness outcome is timely acute reperfusion therapy. The secondary effectiveness outcomes include false-positive cardiac catheterization laboratory activation for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and major bleeding events. Multivariable logistic regression model will be developed to identify baseline characteristics that are independently associated with timely acute reperfusion therapy. Propensity score analysis will be performed for comparing clinical outcomes between timely acute reperfusion therapy recipients and non-recipients.

Conditions

Interventions

OTHER

Daily practice care for patients with suspected of STEMI

N/A: Practice care evaluation in real-life setting

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Loïc E BELLE, MD · CH Annecy Genevois, head of RENAU (Réseau Nord Alpin des Urgences)

  • José LABARERE, MD, PhD · Centre Hospitalier Universitaire Grenoble Alpes, France

  • Gérald VANZETTO, MD, PhD · Centre Hospitalier Universitaire Grenoble Alpes, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-05-31
Completion
2017-06-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788344 on ClinicalTrials.gov