Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04378504
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-05-04
Brief Title:
In Hospital Course of Acute Coronary Artery Syndromes
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HACSA
Brief Summary:
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
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
Detailed Description:
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 13 of ACS admission in ICU will have very few events and no fatal events and that they dont need intensive care admission
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 13 of ACS admission in ICU will have very few events and no fatal events and that they dont need intensive care admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None