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CCTA for Coronary Artery Disease (CarDIA-AI Trial)

N/A

Waitlist Available

Led By Jon-David Schwalm, MD, MSc

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥18 years of age

Patients with an indication for ICA that includes 'Rule out CAD', 'Cardiomyopathy', or 'Stable CAD'

Must not have

Patients with planned non-coronary cardiac surgery

Patients with any prior obstructive CAD, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days (after randomization)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the diagnosis of coronary artery disease (CAD) by using a non-invasive test called cardiac computed tomographic angiography (CCTA) instead of the traditional invasive coronary angi

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not detailed in the provided information, generally, risks of CCTA include exposure to radiation and possible allergic reactions to contrast dye. Invasive angiography carries risks like bleeding, infection, and rare cases of heart attack or stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I need a heart artery check for chest pain, heart muscle disease, or stable heart artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have atrial fibrillation.

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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days (after randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days (after randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (after randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of normal/non-obstructive CAD diagnosed through ICA

Secondary study objectives

Budget impact of new strategy for risk stratification of CAD in low-risk patients

Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)

Diagnostic yield of invasive angiography

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Centralized triage with risk score-based screening for obstructive CADExperimental Treatment1 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 CareActive Control1 Intervention

Patients will proceed directly to ICA as originally referred.

0 / 6Eligibility criteria met