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

January 15, 2024 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • UH Montpellier
        • Contact:
          • Florence LECLERCQ, MD
        • Principal Investigator:
          • Florence LECLERCQ, MD
      • Toulouse, France, 31050
        • Withdrawn
        • Uh Toulouse
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • UH Nîmes
        • Contact:
          • Benoit LATTUCA, MD
        • Principal Investigator:
          • Benoit LATTUCA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intensive care unit
systematic intensive care unit (ICU) monitoring
Other: Hospitalized in Intensive care unit
Patient hospitalized in Intensive care unit with ECG monitoring
Experimental: General cardiology ward
Group without ECG monitoring
Other: Hospitalized in General cardiology ward
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 +/- 3 days after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
Time Frame: 1 month follow up
number of low vs high risk NSTEMI (flow chart)
1 month follow up
Incidence of each event included in the combined primary outcome
Time Frame: 1 month follow up
evaluation of each event of combined primary end point
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
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
Time Frame: though hospital follow up, an average of 5 days
ICU length of stay in the control group in days
though hospital follow up, an average of 5 days
Evolution of patient satisfaction (questionnaire)
Time Frame: 1 month +/- 7 days after inclusion
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
Time Frame: 1 month +/- 7 days after inclusion
total mortality in both arms
1 month +/- 7 days after inclusion
Comparison of cardiovascular mortality in both arm
Time Frame: 1 month +/- 7 days after inclusion
cardiovascular mortality in both arms
1 month +/- 7 days after inclusion
Comparison of new hospitalization for cardiac event in both arms
Time Frame: 1 month +/- 7 days after inclusion
new hospitalization for cardiac reasons
1 month +/- 7 days after inclusion
Comparison of direct medical cost of the initial inpatient stay in both arm
Time Frame: during hospitalization stay
economic study regarding medical cost
during hospitalization stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0270
  • 2021-A02234-37 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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