Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission
SELECTNSTEMI
2 other identifiers
interventional
320
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
December 10, 2021
CompletedStudy Start
First participant enrolled
December 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJanuary 17, 2024
January 1, 2024
3.5 years
October 27, 2021
January 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success of the experimental strategy defined by absence of major adverse events 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
4 +/- 3 days after inclusion
Secondary Outcomes (9)
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
1 month follow up
Incidence of each event included in the combined primary outcome
1 month follow up
Comparison of hospitalization length of stay for the 2 groups
though hospital follow up, an average of 5 days
ICU length of stay in the control group
though hospital follow up, an average of 5 days
Evolution of patient satisfaction (questionnaire)
1 month +/- 7 days after inclusion
- +4 more secondary outcomes
Study Arms (2)
Intensive care unit
OTHERsystematic intensive care unit (ICU) monitoring
General cardiology ward
EXPERIMENTALGroup without ECG monitoring
Interventions
Patient hospitalized in Intensive care unit with ECG monitoring
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UH Nîmes
Nîmes, Gard, 30029, France
UH Montpellier
Montpellier, 34295, France
UH Toulouse
Toulouse, 31050, France
Related Publications (3)
Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K; PAC-Man study collaboration. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet. 2005 Aug 6-12;366(9484):472-7. doi: 10.1016/S0140-6736(05)67061-4.
PMID: 16084255BACKGROUNDBonnefoy-Cudraz E, Bueno H, Casella G, De Maria E, Fitzsimons D, Halvorsen S, Hassager C, Iakobishvili Z, Magdy A, Marandi T, Mimoso J, Parkhomenko A, Price S, Rokyta R, Roubille F, Serpytis P, Shimony A, Stepinska J, Tint D, Trendafilova E, Tubaro M, Vrints C, Walker D, Zahger D, Zima E, Zukermann R, Lettino M. Editor's Choice - Acute Cardiovascular Care Association Position Paper on Intensive Cardiovascular Care Units: An update on their definition, structure, organisation and function. Eur Heart J Acute Cardiovasc Care. 2018 Feb;7(1):80-95. doi: 10.1177/2048872617724269. Epub 2017 Aug 17.
PMID: 28816063BACKGROUNDCollet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
PMID: 32860058BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2021
First Posted
December 10, 2021
Study Start
December 18, 2021
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
January 17, 2024
Record last verified: 2024-01