Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department

Stopped early

Conditions studied: Coronary Artery Disease

In brief

This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the emergency department (ED) or observation unit with suspected coronary artery disease (CAD) and who have at least one ≥40% lesion and no lesion \>90% confirmed by CCTA (Coronary Computed Tomography Angiogram) are eligible for enrollment once their CCTA has been completed and their FFR-CT (if applicable) has been ordered. All enrolling sites will have CCTA incorporated into their standard evaluation of chest pain in the ED/observation unit. Non-control sites will have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.

Key facts

Study ID

NCT05325112

Run by

HeartFlow, Inc.

People needed

18

Starts

2022-07-15

Expected to finish

2022-11-14

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Clinically stable, symptomatic patients who present to ED/observation unit with suspected CAD
• CCTA shows at least one ≥40% lesion and no lesions >90% in at least one major epicardial vessel
• FFR-CT processed successfully (if applicable)
• EKG with no acute ischemic changes
• Willing to comply with all aspects of the protocol, including adherence to follow up visit
• Agrees to be included in the study
• Able to provide written informed consent

You may not qualify if…

• CCTA showing no ≥40% lesion in a major epicardial vessel
• CCTA showing a lesion >90% in a major epicardial vessel
• CCTA showing other incidental, non-cardiac findings requiring admission, e.g., pneumonia, pulmonary embolism, or aortic dissection
• Uninterpretable CCTA which is not of diagnostic quality
• Coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) prior to CCTA acquisition
• Left main lesion >50%
• Confirmed acute coronary syndrome (acute myocardial infarction or unstable angina)
• Known complex congenital heart disease or any history of coronary artery disease
• Patients with tachycardia or significant arrhythmia which cannot be adequately controlled with medications to allow CTA
• Any active, serious, life-threatening disease with a life expectancy of less than 2 months
• Inability to comply with follow-up requirements
• Currently enrolled in another study utilizing FFR-CT or in an investigational trial that involves a non-approved cardiac drug or device
• Persons under the protection of justice, guardianship, or curatorship

Where it is running

• UMass Memorial Hospital — Worcester, Massachusetts, United States
• University Hospital Clevelan — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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