Acute Coronary Syndrome, Left Ventricular Dysfunction
Conditions
Keywords
acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
Brief summary
Left ventricular ejection fraction (LVEF) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (ACS). Transthoracic echocardiography (TTE) remains the gold standard for LVEF measurement. Currently, LVEF can be estimated at the time of the coronary angiogram but requires a ventriculography. This latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. Artificial intelligence (AI) has previously been shown to be an accurate method for determining LVEF using different data sources. Fur the purpose of this study, we aim at validating prospectively an AI algorithm, called CathEF, for the prediction of real-time LVEF (AI-LVEF) compared to TTE-LVEF and ventriculography in patients undergoing coronary angiogram for ACS.
Interventions
None listed
Sponsors
Ottawa Heart Institute Research Corporation
Montreal Heart Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed by the participant * Acute coronary syndrome * Creatinine clearance ≥30 ml/min/m2 according to MDRD
Exclusion criteria
* Creatinine clearance \<30 ml/min/m2 according to MDRD * No indication to perform TTE in the 7 days following coronary angiogram * Right bundle branch block * Suspected or confirmed left ventricular thrombus * Suspected or confirmed aortic dissection * Ventriculography not feasible * No left coronary system angiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF | Either 7 days before or up to 7 days after the coronary angiogram |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF. | Either 7 days before or up to 7 days after the coronary angiogram |
| Specificity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF. | Either 7 days before or up to 7 days after the coronary angiogram |
| Number of participants with major adverse cardiovascular events (Combined outcome of combined outcomeof mortality, ventricular arrhythmia requiring an intervention, heart failure, need for inotropic support, renal failure KDIGO≥2 and stroke) | At 7 days or before discharge, if earlier. |
| Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50% | Either 7 days before or up to 7 days after the coronary angiogram |
| Sensitivity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50% | Either 7 days before or up to 7 days after the coronary angiogram |
| Specificity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50% | Either 7 days before or up to 7 days after the coronary angiogram |
| Likert scale on the impact on the procedure, ease of use and utility of the CathEF algorithm in the clinical practice, as assessed by interventional cardiologists | Through study completion, an average of 1 year. |
| AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50% | Either 7 days before or up to 7 days after the coronary angiogram |
Countries
Canada
Outcome results
None listed