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New CT scan analysis could spare thousands from unnecessary heart catheterizations

NCT ID NCT01943903

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested whether a computer analysis of CT scans (called FFRCT) can better guide decisions about heart artery blockages compared to usual care. About 584 people with suspected coronary artery disease took part. The goal was to see if using FFRCT reduces the number of unnecessary invasive angiograms (where a tube is inserted into heart arteries).

What this could mean

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

Active substance
FFRCT (a computer analysis of CT scans to measure blood flow in heart arteries)
What this could lead to
If successful, this could show that FFRCT helps doctors diagnose blocked arteries more accurately, reducing the need for invasive tests.
What could go wrong
This is a completed study, so results are already known. The test may not work as well in all patients or settings, and it adds extra cost and time to standard CT scans.

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

584 people

The number who actually took part.

Start date

Sep 2013

Finished

Dec 2015

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

Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD

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: * Age \>18 years * Providing written informed consent * Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who: * In Cohort 1A \& 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or * In Cohort 1B \& 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days * Ability to undergo cCTA Exclusion Criteria: * Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction. * Prior, clinically documented myocardial infarction * PCI prior to first test * CABG prior to first test * Contraindications for cCTA such as: * Presence of pacemaker or internal defibrillator leads * Atrial Fibrillation * Known anaphylactic allergy to iodinated contrast * Pregnancy or unknown pregnancy status in women of childbearing potential * Body mass index \>35 kg/m2 * Contraindication to acute beta blockade * Contraindication to acute sublingual nitrate administration * Prosthetic heart valve * Contraindications to FFRCT * Complex Congenital Heart disease other than anomalous coronary origins alone * Ventricular septal defect with known Qp/Qs\>1.4 * Requiring an emergent procedure within 48 hours of presentation * Evidence of active clinical instability, including cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or NYHA Grade III or IV congestive heart failure or acute pulmonary edema * Any active, serious, life-threatening disease with a life expectancy of less than 2 years * Inability to comply with study follow-up requirements * Current participation in any other clinical trial involving an investigational device or dictating care pathways at the time of enrollment.

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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

  • Aarhus University Hospital Skejby

    Aarhus, 8200, Denmark

  • CHU Brest - Hopital de Cardiologie

    Brest, 29609, France

  • Cardiovascular Center Aalst

    Aalst, Belgium

  • Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France

    Lyon, 69677, France

  • Centro Cardiologico Monzino

    Milan, 20154, Italy

  • Deutsches Herzzentrum München - ISAResearch Centre

    Munich, 80636, Germany

  • Duke University Clinical Research Institution

    Durham, North Carolina, 27705, United States

  • Freeman Hospital - Therapeutics & Cardiac Research Team

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Heart Center Leipzig GmbH

    Leipzig, 04289, Germany

  • HeartFlow, Inc

    Redwood City, California, 94063, United States

  • Innsbruck Medical University, Department of Radiology II

    Innsbruck, A-6020, Austria

  • LKH-GRAZ-West - Department of Cardiology

    Graz, A-8020, Austria

  • Stanford University

    Stanford, California, 94305, United States

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

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