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New heart scan could help ER doctors spot artery blockages faster

NCT ID NCT05325112

Diagnosis Sponsor: HeartFlow, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a special CT scan called FFR-CT can help emergency room doctors better diagnose coronary artery disease in patients with chest pain. The plan was to compare treatment decisions made with and without the FFR-CT results. However, the study was stopped early after enrolling only 18 people, so no data was collected or analyzed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FFR-CT (a non-invasive diagnostic test that uses CT scan images to measure blood flow in the heart arteries)
What this could lead to
If successful, this could help emergency doctors more accurately decide who needs further heart tests or procedures, potentially reducing unnecessary hospital stays and invasive procedures.
What could go wrong
The study was terminated early with only 18 participants enrolled, so no results were collected or analyzed. It is unclear if FFR-CT would actually improve patient care in the emergency setting.

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

18 people

The number who actually took part.

Started

Jul 2022

Finished

Nov 2022

Lead sponsor

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

Clinically stable, symptomatic patients who present to the ED with suspected coronary artery disease and no history of coronary artery disease, and who while in the ED have a CCTA performed which shows at least one ≥40% lesion and no lesions \>90% in a major epicardial vessel, and a successfully processed FFR-CT (if applicable).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years 2. Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD 3. CCTA shows at least one ≥40% lesion and no lesions \>90% in at least one major epicardial vessel 4. FFR-CT processed successfully (if applicable) 5. EKG with no acute ischemic changes 6. Willing to comply with all aspects of the protocol, including adherence to follow up visit 7. Agrees to be included in the study 8. Able to provide written informed consent Exclusion Criteria: 1. CCTA showing no ≥40% lesion in a major epicardial vessel 2. CCTA showing a lesion \>90% in a major epicardial vessel 3. CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection 4. Uninterpretable CCTA which is not of diagnostic quality 5. Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition 6. Left main lesion \>50% 7. Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina) 8. Known complex congenital heart disease or any history of coronary artery disease 9. Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA 10. Any active, serious, life-threatening disease with a life expectancy of less than 2 months 11. Inability to comply with follow-up requirements 12. Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device 13. Persons under the protection of justice, guardianship, or curatorship

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01605, United States

  • University Hospital Clevelan

    Cleveland, Ohio, 44106, United States

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