NCT05153889

Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission

Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Favourable in-hospital outcome is observed in numerous patients after Non ST myocardial infarction (NSTEMI) with invasive strategy but European guidelines proposed systematic intensive care unit monitoring up to 24 h in lower risk patients (grade 1, level of evidence C). Regarding absence of prospective study supporting this strategy, we assessed the hypothesis that the lower risk NSTEMI patients identified through simple medical criteria and after coronary angiography evaluation may not require intensive care unit admission.

Detailed description

The incidence of serious in hospital complications after NSTEMI has dramatically decreased over the past decades mainly due to early coronary angioplasty with new generation drug eluting stents surrounded by an optimal antithrombotic treatment (1). Major in-hospital adverse events after NSTEMI became uncommon and above all appears predictable including unstable hemodynamic state, acute stent thrombosis and life threatening arrhythmia (5-7). Recent 2020 European guidelines recommended that all patients with NSTEMI should be monitored up to 24 hours or up to percutaneous coronary intervention (PCI) in the intensive care unit (ICU) and rhythm monitoring \> 24 h in patients at intermediate or high risk of cardiac arrhythmia (2). However, the usefulness of systematic ICU admission and ECG monitoring, for lower risk patients particularly when they have been stabilized with successful (PCI) has never been evaluated in a randomized study and remain controversial (8-10). The main objective of this randomized study is to validate the feasibility and safety of a strategy without intensive care unit admission of lower risk NSTEMI patients after coronary angiography evaluation and successful PCI when required, compared to the conventional strategy using systematic ICU monitoring. All patients admitted in our hospital for NSTEMI (initial admission of patients in ICU or directly in the cath lab) will have systematic coronary angiography evaluation and PCI when required. They will be classified as low or high risk patients related to guidelines derived criteria including results of coronary angiography evaluation. Low risk patients will be randomized in ICU admission group (control group) or general cardiology ward (GCW) group (experimental group) without ECG monitoring.

Conditions

• Non-ST Elevated Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Hospitalized in Intensive care unit	Patient hospitalized in Intensive care unit with ECG monitoring
OTHER	Hospitalized in General cardiology ward	Patient hospitalized in General cardiology ward without ECG monitoring. patients randomized in this group will not be hospitalized in intensive care unit unless an event require intensive care unit monitoring.

Timeline

• Start date: 2021-12-18
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-12-10
• Last updated: 2024-01-17

Locations

3 sites across 1 country: France