CCTA for Coronary Artery Disease

(CarDIA-AI Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Jeremy Petch, PhD

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}

Research Team

Jon-David Schwalm, MD, MSc

Principal Investigator

Hamilton Health Sciences Corporation

Natalia Pinilla-Echeverri, MD, PhD

Principal Investigator

Niagara Health

Jeremy Petch, PhD

Principal Investigator

Hamilton Health Sciences Corporation

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.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University

Hamilton Academic Health Sciences Organization

Collaborator

Trials

22

Recruited

5,200+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Dr. Salim Yusuf

Population Health Research Institute

Chief Executive Officer since 2001

MD, McMaster University

Dr. Sonia Anand

Population Health Research Institute

Chief Medical Officer since 2015

MD, McMaster University

Findings from Research

In a study of 8030 patients who underwent coronary computed tomography angiography (CCTA), only 12.03% required further coronary angiography (CAG), indicating that CCTA can effectively triage patients and reduce unnecessary procedures.

Among those who did undergo CAG after CCTA, there was a significantly higher revascularization rate (63.4% underwent PCI) compared to patients who had direct CAG, suggesting that CCTA improves the accuracy of identifying patients who need further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of coronary computed tomography angiography on patient triage strategies]. Gai, J., Zhai, X., Bai, Q., et al.[2016]

Using Computer Aided Diagnosis (CAD) with Coronary Computed Tomographic Angiography (CCTA) can effectively triage 60% of low to intermediate risk chest pain patients in the Emergency Department, potentially reducing patient wait times.

The CAD demonstrated a sensitivity of approximately 85% and a high Negative Predictive Value (NPV) of 97.8% for the 64-slice scanner and 97.1% for the 320-slice scanner, indicating it is reliable for ruling out serious conditions, although it should not completely replace human interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided analysis of 64- and 320-slice coronary computed tomography angiography: a comparison with expert human interpretation. Abd Alamir, M., Noack, P., Jang, KH., et al.[2019]

Coronary computed tomography angiography (CCTA) is a safe and effective method for triaging patients with low-to-intermediate likelihood of acute coronary syndrome, allowing for quick discharge if no coronary artery disease (CAD) is present.

Using CCTA can significantly reduce hospital length of stay and may lead to cost-effective care compared to traditional triage methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac computed tomography for the evaluation of the acute chest pain syndrome: state of the art. Schlett, CL., Hoffmann, U., Geisler, T., et al.[2022]

The study will evaluate a low-dose CCTA protocol for diagnosing acute chest pain in 681 younger adults, aiming to demonstrate that it is safe and effective, with a target of less than 1% chance of hard events within 30 days after a negative result.

If successful, this low-dose approach could reduce radiation exposure and costs without needing to invest in new technology, making it a practical option for emergency departments.

NCBI (Pubmed)

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. Kim, J., Kang, JW., Kim, K., et al.[2020]

Cardiac computed tomography angiography (CCTA) demonstrated high diagnostic accuracy in detecting significant coronary artery stenosis, with a sensitivity of 99% and specificity of 81% in a study of 400 patients with non-ST segment elevation myocardial infarction.

CCTA effectively triaged patients into appropriate treatment groups 86% of the time, indicating its potential utility in managing high-risk coronary artery disease patients, although logistical and safety challenges limit its current use as a routine diagnostic tool before invasive coronary angiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary CT angiography in clinical triage of patients at high risk of coronary artery disease. Kühl, JT., Hove, JD., Kristensen, TS., et al.[2019]

References

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

[Impact of coronary computed tomography angiography on patient triage strategies]. [2016]

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]

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]

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]

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

Accuracy of telephone triage in primary care patients with chest discomfort: a cross-sectional study. [2020]

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]

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]

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

Coronary CT angiography in clinical triage of patients at high risk of coronary artery disease. [2019]