In Hospital Course of Acute Coronary Artery Syndromes

NCT04378504 | Completed

• 1 other identifier: RECHMPL20_0271
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

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 .

Conditions

Acute Coronary Syndrome; Intensive Care Unit Syndrome

Keywords

Acute coronary syndromes; Intensive care unit; Coronary angiography; In hospital events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• all-cause and cardiovascular mortality

  1 month

Study Arms (1)

ACS

All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020

You may qualify if:

• Patients all admitted in ICU after coronary angiography and angioplasty if required

You may not qualify if:

• Patients not admitted in ICU
• Patients without coronary angiography evaluation
• lack of patient consent

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Akodad M, Meunier PA, Padovani C, Cayla G, Zitouni W, Macia JC, Robert P, Steinecker M, Roubille F, Leclercq F. Identification of Low- versus High-Risk Acute Coronary Syndrome for a Selective ECG Monitoring Strategy. J Clin Med. 2023 Jul 11;12(14):4604. doi: 10.3390/jcm12144604.

  PMID: 37510718 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Florence Leclercq, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: July 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

FR (1)