search
Back to results

Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission (SELECTNSTEMI)

Primary Purpose

Non-ST Elevated Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hospitalized in Intensive care unit
Hospitalized in General cardiology ward
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-ST Elevated Myocardial Infarction focused on measuring Intensive Care Unit; General Cardiology Ward; ECG monitoring; Low risk NSTEMI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 admission in ICU
  • Pregnant or breastfeeding woman
  • Patient unable or refusing to sign inform consent
  • Patient without health care insurance
  • Patient under legal guardianship

Sites / Locations

  • UH NîmesRecruiting
  • UH MontpellierRecruiting
  • UH Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Intensive care unit

General cardiology ward

Arm Description

systematic intensive care unit (ICU) monitoring

Group without ECG monitoring

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
number of low vs high risk NSTEMI (flow chart)
Incidence of each event included in the combined primary outcome
evaluation of each event of combined primary end point
Comparison of hospitalization length of stay for the 2 groups
lenght of stay in ICU and total hospitalization stay in days
ICU length of stay in the control group
ICU length of stay in the control group in days
Evolution of patient satisfaction (questionnaire)
a short 5 questions by phone regarding satisfaction in the 2 groups
Comparison of total mortality in both arm
total mortality in both arms
Comparison of cardiovascular mortality in both arm
cardiovascular mortality in both arms
Comparison of new hospitalization for cardiac event in both arms
new hospitalization for cardiac reasons
Comparison of direct medical cost of the initial inpatient stay in both arm
economic study regarding medical cost

Full Information

First Posted
October 27, 2021
Last Updated
September 26, 2023
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT05153889
Brief Title
Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission
Acronym
SELECTNSTEMI
Official Title
Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST Elevated Myocardial Infarction
Keywords
Intensive Care Unit; General Cardiology Ward; ECG monitoring; Low risk NSTEMI

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive care unit
Arm Type
Other
Arm Description
systematic intensive care unit (ICU) monitoring
Arm Title
General cardiology ward
Arm Type
Experimental
Arm Description
Group without ECG monitoring
Intervention Type
Other
Intervention Name(s)
Hospitalized in Intensive care unit
Intervention Description
Patient hospitalized in Intensive care unit with ECG monitoring
Intervention Type
Other
Intervention Name(s)
Hospitalized in General cardiology ward
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success of the experimental strategy defined by absence of major adverse events 4 +/- 3 days after inclusion
Description
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
Time Frame
4 +/- 3 days after inclusion
Secondary Outcome Measure Information:
Title
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
Description
number of low vs high risk NSTEMI (flow chart)
Time Frame
1 month follow up
Title
Incidence of each event included in the combined primary outcome
Description
evaluation of each event of combined primary end point
Time Frame
1 month follow up
Title
Comparison of hospitalization length of stay for the 2 groups
Description
lenght of stay in ICU and total hospitalization stay in days
Time Frame
though hospital follow up, an average of 5 days
Title
ICU length of stay in the control group
Description
ICU length of stay in the control group in days
Time Frame
though hospital follow up, an average of 5 days
Title
Evolution of patient satisfaction (questionnaire)
Description
a short 5 questions by phone regarding satisfaction in the 2 groups
Time Frame
1 month +/- 7 days after inclusion
Title
Comparison of total mortality in both arm
Description
total mortality in both arms
Time Frame
1 month +/- 7 days after inclusion
Title
Comparison of cardiovascular mortality in both arm
Description
cardiovascular mortality in both arms
Time Frame
1 month +/- 7 days after inclusion
Title
Comparison of new hospitalization for cardiac event in both arms
Description
new hospitalization for cardiac reasons
Time Frame
1 month +/- 7 days after inclusion
Title
Comparison of direct medical cost of the initial inpatient stay in both arm
Description
economic study regarding medical cost
Time Frame
during hospitalization stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence LECLERCQ, MD
Phone
0467336188
Email
f-leclercq@chu-montpellier.fr
Facility Information:
Facility Name
UH Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit LATTUCA, MD
First Name & Middle Initial & Last Name & Degree
Benoit LATTUCA, MD
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence LECLERCQ, MD
First Name & Middle Initial & Last Name & Degree
Florence LECLERCQ, MD
Facility Name
UH Toulouse
City
Toulouse
ZIP/Postal Code
31050
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meyer ELBAZ, MD
First Name & Middle Initial & Last Name & Degree
Meyer ELBAZ, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16084255
Citation
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.
Results Reference
background
PubMed Identifier
28816063
Citation
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.
Results Reference
background
PubMed Identifier
32860058
Citation
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. Erratum In: Eur Heart J. 2021 May 14;42(19):1908. Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;:
Results Reference
background

Learn more about this trial

Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission

We'll reach out to this number within 24 hrs