Acute Coronary Syndrome Clinical Trial
— HACSAOfficial title:
Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area
NCT number | NCT04378504 |
Other study ID # | RECHMPL20_0271 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | July 1, 2020 |
Verified date | July 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 .
Status | Completed |
Enrollment | 269 |
Est. completion date | July 1, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - ACS with or without ST elevation during the inclusion period (May 2019 to May 2020) - Patients all admitted in ICU after coronary angiography and angioplasty if required Exclusion criteria: - Patients not admitted in ICU - Patients without coronary angiography evaluation - lack of patient consent |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical evaluation during hospitalization | all causes of death, 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, secondary transfer to intensive care for any reason | 1 day | |
Secondary | all-cause and cardiovascular mortality | 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 : One month follow up (by phone or medical consultation) | 1 month |
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