Evaluating ICU admission necessity for low-risk NSTEMI patients
Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study
This study is trying to see if low-risk NSTEMI patients really need to be admitted to the ICU after their heart procedure, or if they can be safely monitored in a regular hospital room instead.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 3 sites (Nîmes, Gard and 2 other locations) |
| Trial ID | NCT05153889 on ClinicalTrials.gov |
What this trial studies
This study investigates whether low-risk patients with Non-ST Elevated Myocardial Infarction (NSTEMI) require admission to the Intensive Care Unit (ICU) after undergoing coronary angiography and potential percutaneous coronary intervention (PCI). It aims to compare the outcomes of patients admitted to the ICU versus those monitored in a general cardiology ward. The research is based on the hypothesis that many low-risk NSTEMI patients may not need intensive monitoring, which has not been previously validated in a randomized setting. The study will assess the feasibility and safety of this approach, potentially challenging existing guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with low-risk NSTEMI who meet specific clinical criteria.
Not a fit: Patients with high-risk NSTEMI or those requiring intensive monitoring due to unstable conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient use of healthcare resources and improved patient comfort by reducing unnecessary ICU admissions for low-risk NSTEMI patients.
How similar studies have performed: While similar studies have suggested the potential for reduced ICU admissions in low-risk patients, this specific randomized approach has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * STEMI * Unstable angina troponin \<5ng/l\* or \<14ng/l with variation \<4ng/l between 2 dosages )\* Elecsys Roche * High risk NSTEMI if one low risk criteria defined above is absent * Patient with acute coronary syndromes (ACS) requiring transfer to resuscitation unit and not to intensive care unit for any reason * Coronary angiography not performed or performed \> 24 h after first troponin assay in ICU * Pregnant or breastfeeding woman * Patient unable or refusing to sign inform consent * Patient without health care insurance * Patient under legal guardianship
Where this trial is running
Nîmes, Gard and 2 other locations
- UH Nîmes — Nîmes, Gard, France (Recruiting)
- UH Montpellier — Montpellier, France (Recruiting)
- UH Toulouse — Toulouse, France (Withdrawn)
Study contacts
- Study coordinator: Florence LECLERCQ, MD
- Email: f-leclercq@chu-montpellier.fr
- Phone: 0467336188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.