Acute Coronary Syndrome Clinical Trial
Official title:
Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area
While international guidelines have indicated that use of a routine invasive strategy was
favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients
successfully reperfused and carrefully selected may perhaps not benefit of this systematic
strategy. Evaluation of complications occurring in a contemporary population of ACS may help
to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these
data may be an opportunity for testing of strategies to refine triage to less costly hospital
care units. The investigators thus want to compare, through an observational and prospective
study, the event rate of two groups of patients with ACS admitted to ICU . Patients are
classified as "high risk" and "low risk" according to specific medical criteria validated in
the literature. The study will include all consecutive patients admitted for NSTACS and STACS
admitted to the intensive care department of the Montpellier university hospital with the
diagnosis of ACS confirmed by coronary angiography.
Our primary goal is to compare the percentage of patients with at least one serious clinical
event between the high and low risk groups. A serious event is defined by the occurrence
within 7+/-5 days of one of the following criteria: death all causes, serious neurological or
hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or
sustained or poorly tolerated conduction disorders requiring therapeutic intervention,
painful recurrence requiring new coronary angiography, secondary transfer to intensive care
for any reason.
Our hypothesis is that low-risk patients will have very few events and no fatal events and
that they could not require intensive care unit admission .
All patients admitted in the ICU Montpellier University center for ACS from May 2019 to May
2020 will be evaluated and classed as low risk patients (groupe LR) or not low risk patients
(NLR) after coronary angiography evaluation. High risk criteria will include age >80 years,
severe comorbidities, unstable hemodynamic or rhythmic state requiring specific therapeutic
intervention, failure of reperfusion or unsatisfactory result of angioplasty, patients with
residual coronary lesions requiring further revascularization, left ventricular ejection
fraction <40%. Patients who have not received optimal antithrombotic treatment during
angioplasty for any reason will also be considered at high risk, as will patients at risk of
bleeding due to antecedent or associated pathology or taking a long-term anticoagulant
treatment. For the specific case of SCA with ST segment elevation, they will all be included
in the group, except for patients who have been successfully reperfused less than 3 hours
after the onset of pain or who have an open artery during coronary angiography performed
within the first 3 hours.
Our primary endpoint is to compare the percentage of patients with at least one serious
clinical event between the high and low risk groups. A serious event is defined by the
occurrence within 7+/-5 days of one of the following criteria: death all causes, serious
neurological or hemorrhagic complications, hemodynamic instability and severe heart failure,
rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic
intervention, chest pain recurrence requiring new coronary angiography, any secondary
transfer to intensive care for any reason. Secondary endpoints include evaluation of adverse
events (all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and
non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the
two groups, calculation of the average number of serious events per patient The low-risk
group event rate is estimated at 3 percent without any fatal events. It is estimated at 15
percent in the high risk group.
Assuming a frequency of the event of 3% in the low risk group and 15% in the high risk group,
it is necessary to include at least 269 patients, including 196 patients in the high risk
group and 73 patients in the low risk group (for a power of 90% and an alpha risk of 5%).
Our hypothesis is that low-risk patients, about 1/3 of ACS admission in ICU, will have very
few events and no fatal events and that they don't need intensive care admission
;
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