Interventional Recruiting
NCT05153889 on ClinicalTrials.gov
Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission
Official title: Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study
- Sponsor: Hôpital Lapeyronie
- Enrollment: 320 (Estimated)
- Study start: 2021-12-18 (Actual)
- Primary completion: 2025-07-01 (Estimated)
- Study completion: 2025-07-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Supportive Care
Brief 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.
Conditions
- Non-ST Elevated Myocardial Infarction
Intervention / Treatment
- Other: Hospitalized in Intensive care unit
- Other: Hospitalized in General cardiology ward
Primary Outcome Measures
-
Success of the experimental strategy defined by absence of major adverse events 4 +/- 3 days after inclusion
(4 +/- 3 days after inclusion)
Major adverse events include : mortality (total and cardiovascular), severe bleeding (BARC criteria \>2), major vascular events (BARC 3 or 4 criteria) , cardiac failure requiring specific therapy ,acute kidney injury (RAKIN classification ≥grade 2) , major neurologic events confirmed with brain imaging, severe conductive or rhythm disorder, new coronary ischemic event requiring coronary angiography, any medical decision for secondary ICU transfer
Countries
France
Locations and Investigators
-
UH Nîmes, Nîmes, France (Recruiting)
- Benoit LATTUCA, MD
- Benoit LATTUCA, MD (Principal Investigator)
-
UH Montpellier, Montpellier, France (Recruiting)
- Florence LECLERCQ, MD
- Florence LECLERCQ, MD (Principal Investigator)
- UH Toulouse, Toulouse, France (Withdrawn)