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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age \> or = to 18 years

• NSTEMI was defined according guidelines with chest pain with or without ECG modifications and significant troponin elevation (hs-cTn T \*≥ 52 ng/l) or significant variation \> 10 ng/l between 2 dosages between 1 or 3 hours interval) \* Elecsys Roche

• Coronary angiography mandatory \< 24 h after first troponin assay according to 2020 NSTEMI guidelines and PCI if required

• Low risk NSTEMI defined with (all necessary):

‣ Age\<85 years

⁃ Optimal antithrombotic therapy using new generation P2Y12 inhibitors (ticagrelor or prasugrel) or clopidogrel and aspirin with preloading at the latest before PCI

⁃ Success of PCI (one or 2 arteries)

⁃ Low risk of severe arrhythmia (ESC criteria) if none of the following criteria: haemodynamically unstable, major arrhythmias, LVEF \<40%, failed reperfusion, additional critical coronary stenosis of major vessels, complications related to percutaneous revascularization,

⁃ No major comorbidities requiring specific care

⁃ Success of PCI without any event within 30 minutes after the procedure

⁃ Low bleeding risk (ESC criteria) according to CRUSADE criteria validated in NSTEMI

Locations
Other Locations
France
UH Montpellier
RECRUITING
Montpellier
UH Nîmes
RECRUITING
Nîmes
UH Toulouse
WITHDRAWN
Toulouse
Contact Information
Primary
Florence LECLERCQ, MD
f-leclercq@chu-montpellier.fr
0467336188
Time Frame
Start Date: 2021-12-18
Estimated Completion Date: 2025-07
Participants
Target number of participants: 320
Treatments
Other: Intensive care unit
systematic intensive care unit (ICU) monitoring
Experimental: General cardiology ward
Group without ECG monitoring
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov