Clinical trial NCT05317286: LVEF Prediction During ACS Using AI Algorithm Applied on Coronary Angiogram Videos
Official title: Prospective Validation of a Deep Learning Algorithm for Prediction of the Left Ventricular Ejection Fraction From Coronary Angiogram Videos in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Left Ventricular Dysfunction
Keywords: acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Ottawa Heart Institute Research Corporation
First posted: 2022-04-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults treated by percutaneous coronary intervention for ACS in whom left ventriculography is not contra-indicated and TTE-LVEF is expected to be measured in the next 24h to 7 days.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
Secondary outcomes:
measure: Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50%
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: Specificity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: 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)
timeFrame: At 7 days or before discharge, if earlier.
measure: AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: Sensitivity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: Specificity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%
timeFrame: Either 7 days before or up to 7 days after the coronary angiogram
measure: 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
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Robert Avram
state: Quebec
Study officials:
References: