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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02234-37 | Other Identifier | IDRCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive care unit | Other | systematic intensive care unit (ICU) monitoring |
|
| General cardiology ward | Experimental | Group without ECG monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospitalized in Intensive care unit | Other | Patient hospitalized in Intensive care unit with ECG monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab | number of low vs high risk NSTEMI (flow chart) | 1 month follow up |
| Incidence of each event included in the combined primary outcome |
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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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence LECLERCQ, MD | Contact | 0467336188 | f-leclercq@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Nîmes | Recruiting | Nîmes | Gard | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16084255 | Background | 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. | |
| 28816063 |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006760 | Hospitalization |
| D007362 | Intensive Care Units |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Hospitalized in General cardiology ward | Other | 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. |
|
evaluation of each event of combined primary end point
| 1 month follow up |
| Comparison of hospitalization length of stay for the 2 groups | lenght of stay in ICU and total hospitalization stay in days | though hospital follow up, an average of 5 days |
| ICU length of stay in the control group | ICU length of stay in the control group in days | though hospital follow up, an average of 5 days |
| Evolution of patient satisfaction (questionnaire) | a short 5 questions by phone regarding satisfaction in the 2 groups | 1 month +/- 7 days after inclusion |
| Comparison of total mortality in both arm | total mortality in both arms | 1 month +/- 7 days after inclusion |
| Comparison of cardiovascular mortality in both arm | cardiovascular mortality in both arms | 1 month +/- 7 days after inclusion |
| Comparison of new hospitalization for cardiac event in both arms | new hospitalization for cardiac reasons | 1 month +/- 7 days after inclusion |
| Comparison of direct medical cost of the initial inpatient stay in both arm | economic study regarding medical cost | during hospitalization stay |
| UH Montpellier | Recruiting | Montpellier | 34295 | France |
|
| UH Toulouse | Withdrawn | Toulouse | 31050 | France |
| Background |
| Bonnefoy-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. |
| 32860058 | Background | Collet 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006757 | Hospital Units |
| D006268 | Health Facilities |