Non-ST Elevated Myocardial InfarctionSELECTNSTEMINCT05153889
Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission
A study testing Hospitalized in Intensive care unit and Hospitalized in General cardiology ward in people with Non-ST Elevated Myocardial Infarction, run by University Hospital, Montpellier at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-ST Elevated Myocardial Infarction
- What is being tested?
- Hospitalized in Intensive care unit and Hospitalized in General cardiology ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Dec 2021to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient unable or refusing to sign inform consent
- Patient without health care insurance
- Patient under legal guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites, 2 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Florence LECLERCQ, MD
Florence LECLERCQ, MD
- Recruiting
UH Nîmes
Nîmes, Gard, 30029
Benoit LATTUCA, MD
Benoit LATTUCA, MD
- Withdrawn
UH Toulouse
Toulouse, 31050
About this study
Official title: Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study
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.
Read the detailed description
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.
- Conditions
- Non-ST Elevated Myocardial Infarction
- Being tested
- Hospitalized in Intensive care unit, Hospitalized in General cardiology ward
- Keywords
- Intensive Care Unit; General Cardiology Ward; ECG monitoring; Low risk NSTEMI
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalized in Intensive care unitOther
Patient hospitalized in Intensive care unit with ECG monitoring
Hospitalized in General cardiology wardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit | Other | systematic intensive care unit (ICU) monitoring Receives: Other: Hospitalized in Intensive care unit |
| General cardiology ward | Experimental | Group without ECG monitoring Receives: Other: Hospitalized in General cardiology ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 +/- 3 days after inclusion
Secondary outcomes (9)
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
number of low vs high risk NSTEMI (flow chart)
Measured: 1 month follow up
Incidence of each event included in the combined primary outcome
evaluation of each event of combined primary end point
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month +/- 7 days after inclusion
Comparison of total mortality in both arm
total mortality in both arms
Measured: 1 month +/- 7 days after inclusion
Comparison of cardiovascular mortality in both arm
cardiovascular mortality in both arms
Measured: 1 month +/- 7 days after inclusion
Comparison of new hospitalization for cardiac event in both arms
new hospitalization for cardiac reasons
Measured: 1 month +/- 7 days after inclusion
Comparison of direct medical cost of the initial inpatient stay in both arm
economic study regarding medical cost
Measured: during hospitalization stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start18 Dec 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153889
- Sponsor's protocol ID
- RECHMPL21_0270
- Other IDs
- 2021-A02234-37
- Acronym
- SELECTNSTEMI
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16084255Bonnefoy-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.
PubMed 28816063Collet 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.
PubMed 32860058
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study
- ClinicalTrials.gov ID
- NCT05153889
- Acronym / sponsor ID
- SELECTNSTEMI / RECHMPL21_0270
- Conditions
- Non-ST Elevated Myocardial Infarction
- Keywords
- Intensive Care Unit; General Cardiology Ward; ECG monitoring; Low risk NSTEMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit | Other | Other: Hospitalized in Intensive care unitsystematic intensive care unit (ICU) monitoring |
| General cardiology ward | Experimental | Other: Hospitalized in General cardiology wardGroup without ECG monitoring |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospitalized in Intensive care unitPatient hospitalized in Intensive care unit with ECG monitoring | Other | Intensive care unit |
| Hospitalized in General cardiology wardPatient 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. | Other | General cardiology ward |
Primary outcome
Success of the experimental strategy defined by absence of major adverse events 4 +/- 3 days after inclusion
Time frame: 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
9 secondary outcomes
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
Time frame: 1 month follow up
Incidence of each event included in the combined primary outcome
Time frame: 1 month follow up
Comparison of hospitalization length of stay for the 2 groups
Time frame: though hospital follow up, an average of 5 days
ICU length of stay in the control group
Time frame: though hospital follow up, an average of 5 days
Evolution of patient satisfaction (questionnaire)
Time frame: 1 month +/- 7 days after inclusion
Comparison of total mortality in both arm
Time frame: 1 month +/- 7 days after inclusion
Comparison of cardiovascular mortality in both arm
Time frame: 1 month +/- 7 days after inclusion
Comparison of new hospitalization for cardiac event in both arms
Time frame: 1 month +/- 7 days after inclusion
Comparison of direct medical cost of the initial inpatient stay in both arm
Time frame: during hospitalization stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 16084255Harvey 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.
- Background: PubMed 28816063Bonnefoy-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.
- Background: PubMed 32860058Collet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospitalized in Intensive care unit and Hospitalized in General cardiology ward in people with Non-ST Elevated Myocardial Infarction, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence LECLERCQ, MD (0467336188, f-leclercq@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the experimental strategy defined by absence of major adverse events 4 +/- 3 days after inclusion (time frame: 4 +/- 3 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153889, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.