Acute Coronary SyndromeCathEFNCT05317286
LVEF Prediction During ACS Using AI Algorithm Applied on Coronary Angiogram Videos
An observational study of Acute Coronary Syndrome and Left Ventricular Dysfunction, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Left Ventricular Dysfunction
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Informed consent signed by the participant
- Acute coronary syndrome
- Creatinine clearance ≥30 ml/min/m2 according to MDRD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
- Medical subject headings
- Acute Coronary Syndrome, Ventricular Dysfunction, Left
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF
Measured: Either 7 days before or up to 7 days after the coronary angiogram
Secondary outcomes (8)
Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50%
Measured: Either 7 days before or up to 7 days after the coronary angiogram
Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.
Measured: 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.
Measured: 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)
Measured: At 7 days or before discharge, if earlier.
AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%
Measured: 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%
Measured: 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%
Measured: 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
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Responsible party
- Principal investigator, Robert Avram, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317286
- Sponsor's protocol ID
- CathEF
- Acronym
- CathEF
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared to other researchers on reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05317286
- Acronym / sponsor ID
- CathEF / CathEF
- Keywords
- acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Informed consent signed by the participant
- Acute coronary syndrome
- Creatinine clearance ≥30 ml/min/m2 according to MDRD
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF
Time frame: Either 7 days before or up to 7 days after the coronary angiogram
8 secondary outcomes
Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50%
Time frame: Either 7 days before or up to 7 days after the coronary angiogram
Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.
Time frame: 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.
Time frame: 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)
Time frame: At 7 days or before discharge, if earlier.
AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%
Time frame: 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%
Time frame: 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%
Time frame: 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
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared to other researchers on reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Left Ventricular Dysfunction, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF (time frame: Either 7 days before or up to 7 days after the coronary angiogram). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.