ADVANCE-ED: Assessing Diagnostic Value of Non-invasive FFR-CT in Coronary Care in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- HeartFlow, Inc.
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FFR-CT Group
Sites who have CCTA and FFR-CT analysis incorporated into their standard evaluation of chest pain in the ED/observation unit.
Intervention: FFR-CT (Diagnostic Test)
Control Group
Sites who have CCTA but not FFR-CT incorporated into the ED/observation unit.
Outcomes
Primary Outcomes
Reclassification rate between the coronary management plan based on the review of the CCTA alone compared to the coronary management plan based on the review of the CCTA and the FFR-CT analysis.
Time Frame: 30 days
For each enrolled patient, investigators used data from coronary CTA,along with the clinical data such as medical history and demographics todetermine the management plan for the patient. The investigator wouldthen also view the patient's FFR-CT results and determine themanagement plan for the patient with the additional information from theFFR-CT. None of the data was collected or analyzed due to the study'searly termination. No additional procedures occurred due to studytermination, and Patients were treated per standard clinical care.
Secondary Outcomes
- Rate of Major Adverse Coronary Events (MACE)(30 days)
- Cost Utility Analysis(30 days)
- Time to discharge(Within 30 days)
- Time to primary diagnosis(Within 30 days)