CCTA for Coronary Artery Disease

(CarDIA-AI Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Jon-David Schwalm, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Atrial fibrillation, Severe renal dysfunction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Coronary artery disease (CAD) is a leading cause of death. The gold-standard test used to diagnose CAD is invasive coronary angiography (ICA). However, nearly half the patients who receive ICA are found to have no disease or non-significant disease. This means that while they receive a diagnosis, they do not receive any therapeutic benefit. This is concerning because ICA is expensive and it carries a risk to patients. A non-invasive diagnostic test, cardiac computed tomographic angiography (CCTA), has been shown to be as effective as ICA at diagnosing CAD in the right patient population, while being less expensive and less risky for patients. An optimal solution would involve screening to identify which patients are good candidates for CCTA vs. which should receive ICA. This screening tool could be used in a triage pathway to ensure that every patient gets the test that is best for them. The investigators have used Artificial Intelligence (AI) to develop a model for determining which patients should receive ICA vs. which should receive CCTA. The investigators have also developed a triage pathway to direct patients to the most appropriate test. The investigators now plan to evaluate the AI tool combined with the triage pathway through a clinical trial at Hamilton Health Sciences and Niagara Health. This model of care will reduce risk to patients, reduce wait times for ICA and reduce costs to the health care system.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the AI Triage Tool treatment for coronary artery disease?

Research shows that using AI with coronary computed tomography angiography (CCTA) can help quickly and accurately identify patients without coronary artery disease, allowing for faster discharge from the emergency department. The AI tool demonstrated high accuracy, with a strong ability to rule out disease, making it a promising aid in triaging chest pain patients. ^{1 2 3 4 5}

Is CCTA safe for use in humans?

CCTA is considered safe for evaluating chest pain in emergency settings, with studies showing it is as safe as traditional methods and can even reduce hospital stays. A low-dose CCTA protocol is being tested to ensure diagnostic safety while minimizing radiation exposure. ^{1 3 4 6 7}

How does CCTA differ from other treatments for coronary artery disease?

CCTA (Coronary Computed Tomography Angiography) is unique because it is a non-invasive imaging technique used to quickly and accurately assess coronary artery disease, allowing for rapid triage and potentially reducing hospital stays. Unlike traditional methods, it can be enhanced with artificial intelligence to improve diagnostic efficiency and accuracy in emergency settings. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for individuals with suspected coronary artery disease. It aims to determine the best diagnostic approach by using a new AI model to decide if patients should get a non-invasive CCTA scan or an invasive angiography.

Inclusion Criteria

I am 18 years old or older.

I am referred for a non-urgent heart artery check.

Patients able to provide informed consent in English

Exclusion Criteria

I am scheduled for heart surgery that is not on the coronary arteries.

Patients with known severe coronary artery calcification (calcium score >1000)

I have had heart issues like blocked arteries or heart surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Centralized Triage and Risk Score-based Screening

Patients originally referred for ICA will be screened for obstructive CAD with a decision support tool that uses data from their referral forms. Patients will receive either CCTA or ICA based on their predicted probability of obstructive CAD.

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• AI Triage Tool (Artificial Intelligence)

Trial Overview The study tests usual care against a new triage pathway that uses an AI risk score to screen patients. The goal is to see if this method can more accurately direct patients either towards CCTA or ICA, potentially reducing unnecessary procedures and costs.

Participant Groups

Group I: Centralized triage with risk score-based screening for obstructive CAD Experimental Treatment 1 Intervention

Patients originally referred for ICA will be screened for obstructive CAD with a decision support tool that uses data from their referral forms. Patients will receive either CCTA or ICA based on their predicted probability of obstructive CAD.

Group II: Usual Care Active Control 1 Intervention

Patients will proceed directly to ICA as originally referred.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hamilton General Hospital Hamilton, Canada

McMaster University Medical Centre Hamilton, Canada

St. Catharines Hospital St. Catharines, Canada

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation Lead Sponsor

Hamilton Academic Health Sciences Organization Collaborator

Population Health Research Institute Collaborator

References

1. China pubmed.ncbi.nlm.nih.gov

[Impact of coronary computed tomography angiography on patient triage strategies]. [2016] To investigate the triaging pathways of patients after coronary computed tomography angiography (CCTA).

2. United States pubmed.ncbi.nlm.nih.gov

Computer-aided analysis of 64- and 320-slice coronary computed tomography angiography: a comparison with expert human interpretation. [2019] Routine use of CCTA to triage Emergency Department (ED) chest pain can reduce ED length of stay while providing accurate diagnoses. We evaluated the effectiveness of using Computer Aided Diagnosis in the triage of low to intermediate risk emergency chest pain patients with Coronary Computed Tomographic Angiography (CCTA). Using 64 and 320 slice CT scanners, we compared the diagnostic capability of computer aided diagnosis to human readers in 923 ED patients with chest pain. We calculated sensitivity, specificity, Positive Predictive Value and Negative Predictive Value for cases performed on each scanner. We calculated the area under the Receiver Operator Curve (ROC) comparing results for the two scanners to Computer Aided Diagnosis performance as compared to the human reader. We examined index and 30 Day outcomes by diagnosis for each scanner and the human reader. 60% of cases could be triaged by the computer. Sensitivity was approximately 85% for both scanners, with specificity at 50.6% for the 64 slice and at 56.5% for the 320 slice scanner (per person measures). The NPV was 97.8 and 97.1 for the 64 and 320 slice scanners, respectively. Results for the four major vessels were similar with negative predictive values ranging from 97 to 100%. The ROC for Computer Aided Diagnosis for the 64 and 320 Slice Scanners, using the human reader as the gold standard was 0.6794 and 0.7097 respectively. The index and 30 day outcomes were consistent for the human reader and Computer Aided Diagnosis interpretation. Although Computer Aided Diagnosis with CCTA cannot serve completely as a substitute for human reading, it offers excellent potential as a triage tool in busy EDs.

3. United States pubmed.ncbi.nlm.nih.gov

Artificial Intelligence to Assist in Exclusion of Coronary Atherosclerosis During CCTA Evaluation of Chest Pain in the Emergency Department: Preparing an Application for Real-world Use. [2022] Coronary computed tomography angiography (CCTA) evaluation of chest pain patients in an emergency department (ED) is considered appropriate. While a "negative" CCTA interpretation supports direct patient discharge from an ED, labor-intensive analyses are required, with accuracy in jeopardy from distractions. We describe the development of an artificial intelligence (AI) algorithm and workflow for assisting qualified interpreting physicians in CCTA screening for total absence of coronary atherosclerosis. The two-phase approach consisted of (1) phase 1-development and preliminary testing of an algorithm for vessel-centerline extraction classification in a balanced study population (n = 500 with 50% disease prevalence) derived by retrospective random case selection, and (2) phase 2-simulated clinical Trialing of developed algorithm on a per-case (entire coronary artery tree) basis in a more "real-world" study population (n = 100 with 28% disease prevalence) from an ED chest pain series. This allowed pre-deployment evaluation of the AI-based CCTA screening application which provides vessel-by-vessel graphic display of algorithm inference results integrated into a clinically capable viewer. Algorithm performance evaluation used area under the receiver operating characteristic curve (AUC-ROC); confusion matrices reflected ground truth vs AI determinations. The vessel-based algorithm demonstrated strong performance with AUC-ROC = 0.96. In both phase 1 and phase 2, independent of disease prevalence differences, negative predictive values at the case level were very high at 95%. The rate of completion of the algorithm workflow process (96% with inference results in 55-80 s) in phase 2 depended on adequate image quality. There is potential for this AI application to assist in CCTA interpretation to help extricate atherosclerosis from chest pain presentations.

4. United States pubmed.ncbi.nlm.nih.gov

Cardiac computed tomography for the evaluation of the acute chest pain syndrome: state of the art. [2022] Coronary computed tomography angiography (CCTA) is recommended for the triage of acute chest pain in patients with a low-to-intermediate likelihood for acute coronary syndrome. Absence of coronary artery disease (CAD) confirmed by CCTA allows rapid emergency department discharge. This article shows that CCTA-based triage is as safe as traditional triage, reduces the hospital length of stay, and may provide cost-effective or even cost-saving care.

5. England pubmed.ncbi.nlm.nih.gov

Accuracy of telephone triage in primary care patients with chest discomfort: a cross-sectional study. [2020] To assess the accuracy of semi-automatic assisted telephone triage in patients with acute chest discomfort against the diagnosis of acute coronary syndrome (ACS) or other life-threatening events (LTEs).

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Association of Coronary Fat Attenuation Index Quantified by Automated Software on Coronary Computed Tomography Angiography with Adverse Events in Patients with Less than Moderate Coronary Artery Stenosis. [2023] This study analyzed the relationship between the coronary FAI on CCTA and coronary adverse events in patients with moderate coronary artery disease based on machine learning.

7. Korea (South) pubmed.ncbi.nlm.nih.gov

SEALONE (Safety and Efficacy of Coronary Computed Tomography Angiography with Low Dose in Patients Visiting Emergency Room) trial: study protocol for a randomized controlled trial. [2020] Chest pain is one of the most common complaints in the emergency department (ED). Cardiac computed tomography angiography (CCTA) is a frequently used tool for the early triage of patients with low- to intermediate-risk acute chest pain. We present a study protocol for a multicenter prospective randomized controlled clinical trial testing the hypothesis that a low-dose CCTA protocol using prospective electrocardiogram (ECG)-triggering and limited-scan range can provide sufficient diagnostic safety for early triage of patients with acute chest pain.

8. England pubmed.ncbi.nlm.nih.gov

Coronary CT angiography in clinical triage of patients at high risk of coronary artery disease. [2019] To test if cardiac computed tomography angiography (CCTA) can be used in the triage of patients at high risk of coronary artery disease.