AI could spot hidden heart disease without extra needles
NCT ID NCT07676097
First seen Jun 30, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study tests whether an artificial intelligence system called AngioAI+ can accurately diagnose two types of coronary artery disease using standard angiogram images. The research involves 620 adults with suspected coronary artery disease who are already scheduled for an angiogram. The AI's results will be compared to traditional invasive measurements to see if it can reliably detect blockages and microvascular disease, potentially reducing the need for additional procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AngioAI+ software (artificial intelligence diagnostic tool)
- What this could lead to
- If successful, this AI tool could help doctors diagnose coronary artery disease and microvascular problems without extra invasive tests, making diagnosis faster and safer.
- What could go wrong
- This is an observational study testing the software's accuracy against existing methods. The AI may not perform as well in real-world settings or on all patient types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 620 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with acute or chronic coronary artery disease
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with acute or chronic coronary syndromes referred for invasive coronary angiography with clinically indicated coronary physiologic assessment. In patients with acute coronary syndromes, the physiological evaluation will be restricted to non-culprit vessels. * Patients with intermediate CAD (30-90% visual stenosis) with clinically indicated FFR assessment. * Patients with NOCAD (\<30% visual stenosis) with clinically indicated microvascular assessment. Exclusion Criteria: * Patients presenting with ST-elevation * Prior myocardial infarction in the target vessel * Stent implantation in the target vessel within the last 12 months * Previous coronary artery bypass grafting surgery (CABG) * Previous heart valve surgery * Previous heart transplantation * Moderate-to-severe valvular disease * Left ventricular ejection fraction (EF) ≤45% * Hemodynamic instability or cardiogenic shock Angiographic Exclusion Criteria * Left main stenosis≥50% * Chronic total occlusion in the target vessel * CTO in a non-target vessel * Less than thrombolysis in myocardial infarction (TIMI) 3 flow in the target vessel * Target vessel receiving collaterals * Inadequate coronary angiographic images * Ostial lesions * Severe tortuosity
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ascension Saint Thomas
Nashville, Tennessee, 37205, United States
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Christ Hospital
Cincinnati, Ohio, 45219, United States
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Minneapolis Heart
Minneapolis, Minnesota, 55407, United States
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New York University
New York, New York, 10016, United States
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Northwell Health
New York, New York, 10075, United States
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Palo Alto Veterans Administration Hospital
Palo Alto, California, 94304, United States
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Stanford University
Palo Alto, California, 94304, United States
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Valley Health System
Paramus, New Jersey, 07652, United States
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Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States