Assessing Diagnostic Value of Non-invasive FFR-CT (Fractional Flow Reserve - Computed Tomography) in Coronary Care in the Emergency Department (ADVANCE-ED)

HeartFlow

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Diagnostic Test: FFRCT

Study type

Observational

Funder types

Industry

Identifiers

NCT05325112

CP- 909-001

Details and patient eligibility

About

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.

Full description

This is a prospective multi-center study. All clinically stable, symptomatic patients who present to the ED or observation unit with suspected CAD and who have at least one ≥40% lesion and no lesions <90% lesion in a major vessel, confirmed by CCTA, are eligible for enrollment once their CCTA has been completed and 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.

All participating sites will provide demographics, medical history, CCTA images, FFR-CT (for non-control sites), the decision plan post CCTA and pre FFR-CT (for non-control sites), length of stay for patients in the ED/observation unit/hospital, billing reports (UB-04 preferred), 30-day clinical outcomes, and any other hospital or office visits, imaging, and/or procedural data completed prior to the follow-up 30-day visit. Sites which do not have FFR-CT incorporated into the ED/observation unit will be control sites.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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